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Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: A systematic review and meta-analysis
Accepted Manuscript Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis Yanping Gao, Helian Tan, Ren Sun, Jie PII:
S1743-9191(19)30072-X
DOI:
https://doi.org/10.1016/j.ijsu.2019.03.014
Reference:
IJSU 4894
To appear in:
International Journal of Surgery
Received Date: 15 February 2019 Revised Date:
18 March 2019
Accepted Date: 21 March 2019
Please cite this article as: Gao Y, Tan H, Sun R, Jie Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis, International Journal of Surgery, https://doi.org/10.1016/j.ijsu.2019.03.014. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic
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review and meta-analysis
First author: Yanping Gao, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
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Second author: Helian Tan, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
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Third author: Ren Sun, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
Correspondence author: Jie Zhu, Department of Anesthesia, The First People’s Hospital of Zhangjiagang,
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Soochow University, China, 215600. Email: [email protected]
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International Journal of Surgery Author Disclosure Form The following additional information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories then this should be stated.
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Please state any conflicts of interest
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No conflicts of interest exists among authors
We did not receive any funding
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Please state any sources of funding for your research
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Please state whether Ethical Approval was given, by whom and the relevant Judgement’s reference number
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Ethical approval was not required, this is a meta-analysis.
Research Registration Unique Identifying Number (UIN)
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Please enter the name of the registry and the unique identifying number of the study. You can register your research at http://www.researchregistry.com to obtain your UIN if you have not already registered your study. This is mandatory for human studies only.
Reviewregistry669
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If you are submitting an RCT, please state the trial registry number – ISRCTN none
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Author contribution Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors.
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Yanping Gao: writing Helian Tan: data collections Ren Sun: data analysis Jie Zhu: study design
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Jie Zhu
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Guarantor The Guarantor is the one or more people who accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
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Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis
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Abstract Background: Optimal pain management after total hip arthroplasty (THA) remains controversial. We perform a meta-analysis from randomized controlled trials (RCTs) to evaluate the efficacy and safety of fascia iliaca compartment block (FICB) in THA. Methods: In this meta-analysis, we conducted electronic searches of Pubmed, Medline, Cochrane library, and Web of Science before February 2019. We collected RCTs to compare FICB and placebo for pain control after THA. The outcome measurements consisted of pain score, opioid consumption, length of hospitalization and postoperative complications. All data analyses were conducted using STATA 13.0. Cochrane Collaboration’s tool was adopted to assess the risk of bias. Results: Seven RCTs met our inclusion criteria with 165 patients in the FICB groups, and 160 patients in the placebo groups. The present meta-analysis indicated that there were significant differences between the groups in terms of pain score at postoperative 12 hours (WMD=-0.285, 95% CI [-0.460, -0.109], P = 0.002) and 24 hours (WMD=-0.391, 95% CI [-0.723, -0.059], P = 0.021). FICB was associated with significant superior in opioid consumption at postoperative 12 hours (WMD=-5.394, 95% CI [-8.772, -2.016], P = 0.002) and 24 hours (WMD=-6.376, 95% CI [-10.737, -2.016], P = 0.004) compared with placebo. No significant difference was identified regarding length of hospitalization (WMD= 0.112, 95% CI [-0.125, 0.350], P = 0.354). Conclusion: Fascia iliaca compartment block was effective for pain relief during the early post-operative period after total hip arthroplasty. Meanwhile, it reduced the cumulative morphine consumption and the risk of opioid-related adverse effects.
Key words: Total hip arthroplasty, fascia iliaca compartment block, pain, opioid, meta-analysis
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1. Introduction
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Total hip arthroplasty (THA) has been shown well-recognized efficacy in improving pain and joint range of motion for patients with severe hip osteoarthritis and femoral head necrosis [1, 2]. It is reported that more than 280 thousand THAs were performed annually in the US and the incidence was increased along with the aging [3]. A majority of patients suffer moderate to severe pain and it may affect physiological function and mental recovery. Delay rehabilitation is associated with several complications, such as pulmonary infection, deep venous thrombosis (DVT) [4] and pulmonary embolism (PE) [5]. Thus, postoperative pain after THA is a major concern for surgeons and patients. Pain control after THA is still an interesting topic. Effective analgesia results in improved functional recovery and patients’ satisfaction. Although several analgesic methods have been used including local infiltration anesthesia, femoral nerve block, epidural analgesia and patients controlled analgesia [6-8], optimal strategy is still under debate. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus with little side effects [9]. It is reported to effectively block nervi femoralis and nervi cutaneus femoris lateralis when performed by specialists in anesthesiology or orthopedics [10]. Hsu et al [11] reported that comparing with intravenous analgesic, FICB could provide better quality during positioning of femur fracture patients for a spinal block and a shorter time for spinal anesthesia. However, Behrends et al indicated that preoperative FICB did not improve pain control after hip arthroscopy but did result in quadriceps weakness, which may contribute to an increased fall risk. Whether FICB is effective in reducing pain and opioid consumption after total hip arthroplasty remains controversial due to the small number of the published
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studies, as well as the low quality of the present articles. Therefore, we perform a meta-analysis from randomized controlled trials (RCTs) to evaluate the efficacy and safety of FICB in THA. We hypothesized that FICB was associated with less pain scores and morphine consumption without adverse effects.
2. Methods
2.1 Search strategy The work has been reported in line with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (Assessing the methodological quality of systematic reviews) Guidelines. We identified relevant studies by an electronic search consisting of five English language databases： MEDLINE (1966 to January 2019), the Cochrane Central Register of Controlled 2
ACCEPTED MANUSCRIPT Trials, Physiotherapy Evidence Database(PEDro)，EMBASE(1974 to January 2019) and OVID (1946 to January 2019). The keywords and search strategy include: (total hip arthroplasty or total hip replacement) AND (Fascia iliaca compartment block). Where possible, we contacted authors for additional information. Two investigators identified eligible studies and extracted data independently.
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2.2 Search strategy The citations and abstracts generated by the literature search were reviewed by two researchers independently. Inclusion criteria were as follows: (a) patients undergoing THA; (b) fascia iliaca compartment block for postoperative pain management in the experimental group; (c) placebo in the control group; (d) at least one of the following outcome measures was reported: postoperative pain score, opioid consumption, incidence of complications and duration of hospitalization; (e) randomized controlled trials. Exclusion criteria were as follows: (a) reviews, letters and case reports; (b) unavailable data for extraction. A consensus procedure was conducted for study selection. If consensus was not reached, a third reviewer would make a judgment.
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2.3. Date extraction Two researchers independently extracted the data from the included literature. The corresponding author was consulted for details in the case of incomplete data. The following information was extracted: First author name, year of publication, intervening measures, comparable baseline, sample size and outcome measures. Other relevant parameters were also extracted from individual studies.
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2.4 Quality assessment of included studies The Cochrane Collaboration “Risk of bias” tool was used to evaluate the methodological quality of the selected studies. Seven potential risks of bias were judged in the assessment tool: (i) details of randomization method, (ii) allocation concealment, (iii) blinding of participants and personnel, (iv) blind outcome assessment, (v) incomplete outcome data, (vi) selective outcome reporting, and (vii) other sources of bias. Each aspect could further be classified as a low, high or unclear risk. Recommendations Assessment, Development and Evaluation (GRADE) system was used to grading the evidence level. Disagreements were resolved through discussions. 2.5. Statistical Analysis All data analyses were conducted using STATA 13.0. For continuous data, each outcome was calculated using the weighted mean difference (WMD) and 95% 3
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confidence intervals (CIs). Risk difference (RD) with a 95% CI were calculated for dichotomous outcomes. Heterogeneity was examined using I2 statistic. Studies with an I2 < 50% were considered to have low heterogeneity, I2 > 50% were considered high heterogeneity. If there was significant heterogeneity among the studies, the random-effects model was used; otherwise, the fixed-effects model was considered acceptable.
3. Results
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3.1 Literature search Our initial search yielded a total of 208 relevant articles, of which 102 were excluded for duplicate studies and various reason the basis of the titles and abstracts (Figure 1). 97 were excluded for irrelevant articles and one was excluded because of case control and review article. In addition, manual search of relevant reference did not identify any additional studies. At last, seven [12-18] randomized controlled trials (RCTs) were selected for this meta-analysis.
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3.2 Study characteristics participants Descriptive data for the RCTs in this meta-analysis were shown in Table 1. All of them were published between 2007 and 2017, involving 325 participants with a diagnosis of osteonecrosis of the femoral head. Experiential groups received fascia iliaca compartment block for postoperative pain management and control groups received placebo. The mean age ranged from 59-year-old to 81-year-old in FICB groups and 62-year-old to 82-year-old in control groups. Average follow up ranged from 1 week to 3 months.
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3.3 Risk of bias Cochrane Collaboration’s tool was adopted to assess the risk of bias. As shown in Table 2, five RCTs reported that participants were randomized with a computerized random number generator. Four RCTs showed that opaque, sealed envelope was used to make sure allocate concealment. Four studies performed double blinding. All RCTs provided complete outcome data. Other assessment of bias was unclear. Each risk of the bias item was expressed in terms of the percentage across all the included studies, which indicated the proportion of risk levels for each item bias (Table 3). 3.4 Outcome of meta-analysis 3.4.1 Pain score at 12 hour Seven studies compared the difference in the efficacy of FICB and placebo group on visual analogue score (VAS) at 12 hours. There was no significant heterogeneity 4
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3.4.2 Pain score at 24 hour Five RCTs reported the VAS at 24 hour after THA. A random effect modal was used because significant heterogeneity was found (P=0.013, I2=68.5%). The present meta-analysis indicated that there was significant difference between groups regarding the VAS at 24 hour (WMD=-0.391, 95% CI [-0.723, -0.059], P = 0.021, Figure. 3).
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3.4.3 Pain score at 48 hour A total of four RCTs showed the VAS at 48 hour after THA. There was significant heterogeneity and a random effect modal was adopted (P=0.002, I2=80.0%). Our meta-analysis demonstrated that there was no significant difference between groups regarding the VAS at 48 hour (WMD=-0.077, 95% CI [-0.169, 0.324], P = 0.538, Figure. 4).
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3.4.4 Opioid consumption at 12 hour Four studies compared the difference in the efficacy of FICB and placebo group on opioid consumption at 12 hour after THA. A random effect modal was adopted (P<0.001, I2=94.7%). The aggregated results of these studies suggest that FICB could significantly reduce opioid consumption at 12 hour (WMD=-5.394, 95% CI [-8.772, -2.016], P = 0.002, Figure. 5).
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3.4.5 Opioid consumption at 24 hour
Four RCTs involving 231 patients reported the opioid consumption at 24 hour. There is a high heterogeneity between the included studies (I2 = 89.3%, P<0.001). Compared with control group, FICB was associated with a significantly reduction of opioid consumption at 24 hour (WMD=-6.376, 95% CI [-10.737, -2.016], P = 0.004, Figure. 6). 3.4.6 Length of hospitalization Five RCTs provided the outcome of length of hospitalization after THA. No significant heterogeneity was identified in the pooled results, therefore a fixed-effects model was used (I2 = 0.6%, P=0.403). Our study demonstrated that there was no significant difference between groups (WMD= 0.112, 95% CI [-0.125, 0.350], P = 5
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3.4.7 Incidence of complications A total of four RCTs showed the postoperative complications after THA. There was significant heterogeneity and a random effect modal was adopted (P=0.022, I2=50.6%). Our meta-analysis demonstrated that FICB could significantly reduce the occurrence of gastrointestinal reaction and did not increase the risk of falls (RD=-0.049, 95% CI [-0.096, -0.003], P = 0.037, Figure. 8).
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3.4.8 Publication bias and evidence level A low risk of publication bias was shown for the outcome of VAS at 12 hour (Table 4). However, publication bias was a limitation which existed in all meta-analysis. GRADE system was used to grading the evidence level. The overall evidence was moderate, which indicated that further research was likely to significantly alter confidence in the effect estimate and may change the estimate (Table 5).
4. Discussion
To the best of our knowledge, this is the first meta-analysis from RCTs to
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assess the efficacy and safety of FICB for pain control after THA. Our study indicated that FICB was associated with an improved pain relief and decreased opioid consumption. Additionally, FICB could significantly reduce the occurrence of gastrointestinal
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reaction and did not increase the risk of falls. The overall evidence was moderate, which indicated that further research was likely to significantly alter confidence in the
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effect estimate and may change the estimate. With the aging population, osteoarthritis (OA) is more and more common. It was reported that more than fifty million patients suffered from hip osteoarthritis in the USA. THA is the final choice to reduce pain and improve joint function. The annual workload of THA procedures were expected to reach 3.5 million by 2030. It has been a public health issue. Pain control is crucial for functional recovery and rehabilitation after THA. Optimal analgesia could reduce length of hospitalization and postoperative complications. Several analgesia methods have been tried for anesthesia and analgesia in hip replacement. Femoral nerve block is effective and easy to administer, and it can decrease the acute pain. Wiesmann et al [19] reported that single shot femoral nerve block for THA resulted in earlier post-operative care unit discharge capability, 6
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improved lung function during the first six hours and better pain control within the first 24 postoperative hours. Tetsunaga et al [20] demonstrated that there were no clinically significant differences in outcomes between femoral nerve block, epidural analgesia, patient-controlled analgesia after THA. However, some experts have shown that femoral nerve block was associated with a risk of femoral nerve injury and a potential for injury to the femoral vessels [21]. Recently, FICB was recommended and has been widely used for pain management after THA. FICB is an analgesic method which injects local anesthetic under the fascia of the iliacus muscle. It could be operated either guided by ultrasound or with a loss of resistance technique. Currently, the efficacy of safety of FICB for pain control after THA remains controversial due to the limited number of published studies and poor quality of current evidence. Although previous meta-analysis [22] has shown that FICB was effective in reducing pain after total knee replacement and total hip replacement, they were different surgical procedures and it could cause huge clinical heterogeneity. Therefore, we performed the meta-analysis from high quality RCTs and only THA was included. Seven RCTs with 325 patients showed the outcome of pain score. VAS (0-10 cm) was used for pain measurement after THA, and the present meta-analysis indicated that FICB was associated with a significantly reduction of VAS within the first 24 postoperative hours after THA. It was reported that approximately 30%-60% of patients suffered moderate to severe postoperative pain, especially within the first 24 hours after THA [23]. It has been well established that opioid is usually effective for pain relief, but often incurs side-effects that can prolong the length of hospitalization. Morphine, a mu-opioid receptor agonist, relieves pain by binding and activating the receptors in both the central and peripheral nervous systems [24]. As the most widely used narcotic for postoperative pain control, morphine has been reported a high incidence of adverse effects such as nausea, vomiting, headache, and urine retention, which could severely impede the postoperative convalescence [25, 26]. Besides, drug dependence is also a major concern. Thus, it was crucial to decrease opioid consumption so as to improve postoperative recovery. Peripheral nerve block was reported with a morphine-sparing effect and recommended by the UK National Institute of Health and Care Excellence [27]. FICB was operated to block the femoral nerve, the obturator nerve, and the lateral cutaneous nerves. Foss et al supported the use of FICB in acute management of hip fracture pain because it is an effective, easily learned procedure that also may reduce opioid side effects in this fragile, elderly group of patients. Watts et al [28] showed that FICB is as effective as femoral nerve block as part of a multimodal anesthetic regimen for total knee replacement. Currently, there was no reliable evidence regarding the morphine-sparing effect for FICB in THA. In our study, four RCTs provided the outcomes of morphine consumption and the present meta-analysis 7
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5. Conclusion
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indicated that FICB was associated with a significantly reduction of morphine consumption within the first 24 postoperative hours after THA. As is known to us all, intravenous morphine was associated with several side effects. Gastrointestinal reactions were the most common. Effective analgesia could reduce opioid consumption and then decrease the risk of opioids-related complications. A total of four RCTs showed the postoperative complications after THA. The overall incidence of nausea and vomiting is 7/109 in FICB groups compared 16/99 in controls. Our study indicated that the application of FICB could significantly reduce the risk of the postoperative complications. No dose-dependence analysis has been performed because only four RCTs were included and further investigation was still required. Theoretically, FICB increased the risk of fall because of the motor weakness. No significant difference was identified between groups. Several limitations should be acknowledged. Firstly, only seven study with small sample sizes were included and statistical tests may be insufficient. Secondly, publication bias is unavoidable because the identified language was restricted to English. Thirdly, some important outcomes, such as range of motion and functional score were not analyzed. Lastly, substantial heterogeneity was found in some results, which might affect the reliability.
Fascia iliaca compartment block are effective for pain relief during the early post-operative period after total hip arthroplasty. Meanwhile, it can reduce the
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cumulative morphine consumption and the risk of opioid-related adverse effects.
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Provenance and peer review Not commissioned, externally peer-reviewed
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ACCEPTED MANUSCRIPT Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Blinding of outcome assessment (detection bias)
Selective reporting (reporting bias) Other bias
Low risk of bias
Unclear risk of bias
50%
High risk of bias
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Table 3 Risk of bias graph
25%
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Incomplete outcome data (attrition bias)
75%
100%
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No. of patients
Year
Design
Age
Study
Outcomes FICB
Control
FICB
Control
FICB
Follow up
Control
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Study
Gender (Male)
VAS 12-48h
Stevens et al
2007
RCT
THA
22
22
15
11
69
67
opioid consumption 12-24 hour
1 month
length of hospitalization
Deniz et al
Bang et al
2013
2014
2016
RCT
RCT
RCT
24
THA
30
THA
16
THA
THA
20
17
12
32
16
20
13
11
10
7
67
15
7
12
70
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RCT
THA
69
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Shariat et al
2010
RCT
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Badica et al
2009
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Arrola et al
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complications
8
12
61
72
57
VAS 12h
3 months
VAS 12h opioid consumption 12-24 hour
2 months
length of hospitalization
VAS 12-24h
2 weeks
length of hospitalization
VAS 12-48h 59
62
opioid consumption 12-24 hour length of hospitalization
1 week
complications
VAS 12-48h 5
2
81
82
length of hospitalization
1 week
complications
VAS 12-48h, Desmet et al
2017
RCT
THA
42
43
14
19
60
67
opioid consumption 12-24 hour complications
1 month
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Table 1 Characteristics of the included studies
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RCT: randomized controlled trial, TKA: total knee arthroplasty
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Blinding of participates and Random Sequence Generation
Blinding of outcome
Allocation Concealment
Selective Incomplete Outcome Data
personal
assessment
Other bias Reporting
Stevens
low risk
unclear risk
low risk
low risk
low risk
low risk
unclear risk
Arrola
low risk
low risk
low risk
low risk
low risk
low risk
unclear risk
Badica
unclear risk
unclear risk
unclear risk
low risk
low risk
low risk
Shariat
low risk
low risk
low risk
low risk
low risk
low risk
Deniz
unclear risk
high risk
unclear risk
unclear risk
low risk
low risk
Bang
low risk
low risk
low risk
low risk
low risk
low risk
Desmet
low risk
low risk
unclear risk
unclear risk
unclear risk
low risk
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Study
unclear risk
unclear risk
unclear risk
unclear risk
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unclear risk
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Table 2 Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias)
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Blinding of outcome assessment (detection bias) Incomplete outcome data (attrition bias)
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Selective reporting (reporting bias) Other bias 0% Low risk of bias
Unclear risk of bias
25%
50%
75%
100%
High risk of bias
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Table 3 Risk of bias graph
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SE(MD)
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0
0.1
0.3
0.4
MD
0
1
2
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Table 4 Publication bias for VAS at 12 hour
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Quality assessment Limitations
Inconsistency
Indirectness
CRITICAL
WMD=-0.077, 95% CI [-0.169, 0.324]
moderate
CRITICAL
WMD=-5.394, 95% CI [-8.772, -2.016]
moderate
CRITICAL
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
RCT
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
WMD=-6.376, 95% CI [-10.737, -2.016]
moderate
CRITICAL
no serious limitations
no serious inconsistency
no serious indirectness
no serious limitations
WMD= 0.112, 95% CI [-0.125, 0.350]
high
IMPORTANT
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
RD=-0.049, 95% CI [-0.096, -0.003]
moderate
CRITICAL
no serious limitations
RCT
no serious limitations
RCT
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Table 5 The GRADE evidence quality
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RCT
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RCT
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RCT
Complications 4
moderate
no serious limitations
Length of hospitalization 5
WMD=-0.391, 95% CI [-0.723, -0.059]
no serious indirectness
Opioid consumption at 24 hour 4
CRITICAL
no serious inconsistency
Opioid consumption at 12 hour 4
high
no serious limitations
VAS at 48 4
WMD=-0.285, 95% CI [-0.460, -0.109]
RCT
VAS at 24 5
Importance
Imprecision
VAS at 12 7
Quality
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No of studies Design
Effect
Records identified through database searching (n =208)
Additional records identified through other sources (n = 0)
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Records screened (n =106)
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Full-text articles assessed for eligibility (n = 8)
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Included
Eligibility
Screening
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Records after duplicates removed (n =106)
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Identification
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Fig. 1 Flow chart of study selection
Studies included in qualitative synthesis (n = 7)
Studies included in quantitative synthesis (meta-analysis) (n = 7)
Irrelevant article (n=97) Case control study (n=1)
Full-text articles excluded for review studies (n = 1)
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Study
% WMD (95% CI)
Weight
Stevens (2007)
-1.10 (-2.03, -0.17)
3.54
Arrola (2009)
-0.30 (-1.00, 0.40)
6.22
Badica (2010)
-0.50 (-0.86, -0.14)
23.46
Shariat (2013)
0.50 (-0.33, 1.33)
4.46
-0.20 (-0.60, 0.20)
18.91
0.10 (-0.34, 0.54)
15.90
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ID
Deniz (2014)
Desmet (2017) Overall (I-squared = 46.7%, p = 0.081)
-2.03
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Bang (2016)
0
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Fig. 2 Forest plot diagram of VAS at 12 hour
-0.40 (-0.73, -0.07)
27.51
-0.28 (-0.46, -0.11)
100.00
2.03
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Study
%
WMD (95% CI)
Weight
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ID
Stevens (2007)
Shariat (2013)
6.39
-0.30 (-0.90, 0.30)
16.10
-0.30 (-0.50, -0.10)
30.16
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Deniz (2014)
0.00 (-1.18, 1.18)
Bang (2016)
Overall (I-squared = 68.5%, p = 0.013)
NOTE: Weights are from random effects analysis -1.22
0
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Fig. 3 Forest plot diagram of VAS at 24 hour
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Desmet (2017)
-0.10 (-0.52, 0.32)
21.77
-0.90 (-1.22, -0.58)
25.57
-0.39 (-0.72, -0.06)
100.00
1.22
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Study
%
WMD (95% CI)
Weight
Stevens (2007)
0.00 (-0.59, 0.59)
11.67
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ID
Deniz (2014)
Desmet (2017)
Overall (I-squared = 80.0%, p = 0.002)
NOTE: Weights are from random effects analysis
0
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-.652
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Fig. 4 Forest plot diagram of VAS at 48 hour
29.43
0.40 (0.15, 0.65)
25.80
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Bang (2016)
-0.20 (-0.39, -0.01)
0.10 (-0.01, 0.21)
33.10
0.08 (-0.17, 0.32)
100.00
.652
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Study
%
WMD (95% CI)
Weight
-12.00 (-15.29, -8.71)
21.93
-6.20 (-8.70, -3.70)
24.05
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ID
Stevens (2007)
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Badica (2010)
Deniz (2014)
Overall (I-squared = 94.7%, p = 0.000)
NOTE: Weights are from random effects analysis
-15.3
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Desmet (2017)
0
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Fig. 5 Forest plot diagram of opioid consumption at 12 hour
-4.00 (-4.98, -3.02)
27.07
-0.70 (-1.77, 0.37)
26.95
-5.39 (-8.77, -2.02)
100.00
15.3
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%
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Study
WMD (95% CI)
Weight
Stevens (2007)
-17.00 (-22.50, -11.50)
20.09
Badica (2010)
-6.00 (-7.87, -4.13)
27.99
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ID
Deniz (2014)
Overall (I-squared = 89.3%, p = 0.000)
NOTE: Weights are from random effects analysis
-22.5
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Fig. 6 Forest plot diagram of opioid consumption at 24 hour
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-2.00 (-4.13, 0.13)
27.57
-6.38 (-10.74, -2.02)
0
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24.35
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Desmet (2017)
-3.00 (-6.70, 0.70)
22.5
100.00
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%
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Study
WMD (95% CI)
Weight
Stevens (2007)
-0.20 (-0.91, 0.51)
11.14
Badica (2010)
0.50 (0.03, 0.97)
25.03
0.00 (-0.35, 0.35)
45.17
0.20 (-0.58, 0.98)
9.38
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ID
Shariat (2013)
Bang (2016)
Overall (I-squared = 0.6%, p = 0.403)
0
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-.975
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Deniz (2014)
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Fig. 7 Forest plot diagram of length of hospitalization
-0.10 (-0.88, 0.68)
9.28
0.11 (-0.13, 0.35)
100.00
.975
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Study
% RD (95% CI)
Fall Stevens (2007) Deniz (2014) Bang (2016) Desmet (2017) Subtotal (I-squared = 0.0%, p = 0.793) .
0.04 (-0.07, 0.16)
9.39
0.00 (-0.09, 0.09)
14.28
0.03 (-0.05, 0.12)
15.83
0.00 (-0.04, 0.04)
60.50
0.01 (-0.03, 0.04)
100.00
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Nausea Stevens (2007) Deniz (2014) Bang (2016)
. Vomiting Stevens (2007) Deniz (2014) Bang (2016) Desmet (2017) Subtotal (I-squared = 0.0%, p = 0.822) .
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Overall (I-squared = 50.6%, p = 0.022)
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Desmet (2017) Subtotal (I-squared = 0.0%, p = 1.000)
-0.09 (-0.29, 0.11)
12.19
-0.10 (-0.32, 0.12)
10.26
-0.10 (-0.22, 0.02)
33.96
-0.09 (-0.20, 0.01)
43.58
-0.10 (-0.17, -0.03)
100.00
-0.18 (-0.35, -0.01)
15.61
-0.14 (-0.35, 0.06)
11.11
-0.10 (-0.22, 0.02)
32.10
-0.09 (-0.20, 0.01)
41.19
-0.11 (-0.18, -0.05)
100.00
-0.05 (-0.10, -0.00)
.
NOTE: Weights are from random effects analysis -.355
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Fig. 8 Forest plot diagram of postoperative complications
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Weight
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ID
0
.355
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Fascia iliaca compartment block was effective for pain relief after total hip arthroplasty.
Fascia iliaca compartment block reduced the cumulative morphine consumption.
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No increased risk of falls was related to fascia iliaca compartment block.
ACCEPTED MANUSCRIPT I confirm that the relevant data is real and you can get them by consulting
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correspondence author.
S1743-9191(19)30072-X
DOI:
https://doi.org/10.1016/j.ijsu.2019.03.014
Reference:
IJSU 4894
To appear in:
International Journal of Surgery
Received Date: 15 February 2019 Revised Date:
18 March 2019
Accepted Date: 21 March 2019
Please cite this article as: Gao Y, Tan H, Sun R, Jie Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis, International Journal of Surgery, https://doi.org/10.1016/j.ijsu.2019.03.014. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic
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review and meta-analysis
First author: Yanping Gao, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
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Second author: Helian Tan, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
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Third author: Ren Sun, Department of Anesthesia, The First People’s Hospital of Zhangjiagang, Soochow University, China, 215600.
Correspondence author: Jie Zhu, Department of Anesthesia, The First People’s Hospital of Zhangjiagang,
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Soochow University, China, 215600. Email: [email protected]
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International Journal of Surgery Author Disclosure Form The following additional information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories then this should be stated.
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Please state any conflicts of interest
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No conflicts of interest exists among authors
We did not receive any funding
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Please state any sources of funding for your research
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Please state whether Ethical Approval was given, by whom and the relevant Judgement’s reference number
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Ethical approval was not required, this is a meta-analysis.
Research Registration Unique Identifying Number (UIN)
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Please enter the name of the registry and the unique identifying number of the study. You can register your research at http://www.researchregistry.com to obtain your UIN if you have not already registered your study. This is mandatory for human studies only.
Reviewregistry669
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If you are submitting an RCT, please state the trial registry number – ISRCTN none
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Author contribution Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors.
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Yanping Gao: writing Helian Tan: data collections Ren Sun: data analysis Jie Zhu: study design
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Jie Zhu
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Guarantor The Guarantor is the one or more people who accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
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Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis
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Abstract Background: Optimal pain management after total hip arthroplasty (THA) remains controversial. We perform a meta-analysis from randomized controlled trials (RCTs) to evaluate the efficacy and safety of fascia iliaca compartment block (FICB) in THA. Methods: In this meta-analysis, we conducted electronic searches of Pubmed, Medline, Cochrane library, and Web of Science before February 2019. We collected RCTs to compare FICB and placebo for pain control after THA. The outcome measurements consisted of pain score, opioid consumption, length of hospitalization and postoperative complications. All data analyses were conducted using STATA 13.0. Cochrane Collaboration’s tool was adopted to assess the risk of bias. Results: Seven RCTs met our inclusion criteria with 165 patients in the FICB groups, and 160 patients in the placebo groups. The present meta-analysis indicated that there were significant differences between the groups in terms of pain score at postoperative 12 hours (WMD=-0.285, 95% CI [-0.460, -0.109], P = 0.002) and 24 hours (WMD=-0.391, 95% CI [-0.723, -0.059], P = 0.021). FICB was associated with significant superior in opioid consumption at postoperative 12 hours (WMD=-5.394, 95% CI [-8.772, -2.016], P = 0.002) and 24 hours (WMD=-6.376, 95% CI [-10.737, -2.016], P = 0.004) compared with placebo. No significant difference was identified regarding length of hospitalization (WMD= 0.112, 95% CI [-0.125, 0.350], P = 0.354). Conclusion: Fascia iliaca compartment block was effective for pain relief during the early post-operative period after total hip arthroplasty. Meanwhile, it reduced the cumulative morphine consumption and the risk of opioid-related adverse effects.
Key words: Total hip arthroplasty, fascia iliaca compartment block, pain, opioid, meta-analysis
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1. Introduction
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Total hip arthroplasty (THA) has been shown well-recognized efficacy in improving pain and joint range of motion for patients with severe hip osteoarthritis and femoral head necrosis [1, 2]. It is reported that more than 280 thousand THAs were performed annually in the US and the incidence was increased along with the aging [3]. A majority of patients suffer moderate to severe pain and it may affect physiological function and mental recovery. Delay rehabilitation is associated with several complications, such as pulmonary infection, deep venous thrombosis (DVT) [4] and pulmonary embolism (PE) [5]. Thus, postoperative pain after THA is a major concern for surgeons and patients. Pain control after THA is still an interesting topic. Effective analgesia results in improved functional recovery and patients’ satisfaction. Although several analgesic methods have been used including local infiltration anesthesia, femoral nerve block, epidural analgesia and patients controlled analgesia [6-8], optimal strategy is still under debate. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus with little side effects [9]. It is reported to effectively block nervi femoralis and nervi cutaneus femoris lateralis when performed by specialists in anesthesiology or orthopedics [10]. Hsu et al [11] reported that comparing with intravenous analgesic, FICB could provide better quality during positioning of femur fracture patients for a spinal block and a shorter time for spinal anesthesia. However, Behrends et al indicated that preoperative FICB did not improve pain control after hip arthroscopy but did result in quadriceps weakness, which may contribute to an increased fall risk. Whether FICB is effective in reducing pain and opioid consumption after total hip arthroplasty remains controversial due to the small number of the published
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studies, as well as the low quality of the present articles. Therefore, we perform a meta-analysis from randomized controlled trials (RCTs) to evaluate the efficacy and safety of FICB in THA. We hypothesized that FICB was associated with less pain scores and morphine consumption without adverse effects.
2. Methods
2.1 Search strategy The work has been reported in line with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (Assessing the methodological quality of systematic reviews) Guidelines. We identified relevant studies by an electronic search consisting of five English language databases： MEDLINE (1966 to January 2019), the Cochrane Central Register of Controlled 2
ACCEPTED MANUSCRIPT Trials, Physiotherapy Evidence Database(PEDro)，EMBASE(1974 to January 2019) and OVID (1946 to January 2019). The keywords and search strategy include: (total hip arthroplasty or total hip replacement) AND (Fascia iliaca compartment block). Where possible, we contacted authors for additional information. Two investigators identified eligible studies and extracted data independently.
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2.2 Search strategy The citations and abstracts generated by the literature search were reviewed by two researchers independently. Inclusion criteria were as follows: (a) patients undergoing THA; (b) fascia iliaca compartment block for postoperative pain management in the experimental group; (c) placebo in the control group; (d) at least one of the following outcome measures was reported: postoperative pain score, opioid consumption, incidence of complications and duration of hospitalization; (e) randomized controlled trials. Exclusion criteria were as follows: (a) reviews, letters and case reports; (b) unavailable data for extraction. A consensus procedure was conducted for study selection. If consensus was not reached, a third reviewer would make a judgment.
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2.3. Date extraction Two researchers independently extracted the data from the included literature. The corresponding author was consulted for details in the case of incomplete data. The following information was extracted: First author name, year of publication, intervening measures, comparable baseline, sample size and outcome measures. Other relevant parameters were also extracted from individual studies.
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2.4 Quality assessment of included studies The Cochrane Collaboration “Risk of bias” tool was used to evaluate the methodological quality of the selected studies. Seven potential risks of bias were judged in the assessment tool: (i) details of randomization method, (ii) allocation concealment, (iii) blinding of participants and personnel, (iv) blind outcome assessment, (v) incomplete outcome data, (vi) selective outcome reporting, and (vii) other sources of bias. Each aspect could further be classified as a low, high or unclear risk. Recommendations Assessment, Development and Evaluation (GRADE) system was used to grading the evidence level. Disagreements were resolved through discussions. 2.5. Statistical Analysis All data analyses were conducted using STATA 13.0. For continuous data, each outcome was calculated using the weighted mean difference (WMD) and 95% 3
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confidence intervals (CIs). Risk difference (RD) with a 95% CI were calculated for dichotomous outcomes. Heterogeneity was examined using I2 statistic. Studies with an I2 < 50% were considered to have low heterogeneity, I2 > 50% were considered high heterogeneity. If there was significant heterogeneity among the studies, the random-effects model was used; otherwise, the fixed-effects model was considered acceptable.
3. Results
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3.1 Literature search Our initial search yielded a total of 208 relevant articles, of which 102 were excluded for duplicate studies and various reason the basis of the titles and abstracts (Figure 1). 97 were excluded for irrelevant articles and one was excluded because of case control and review article. In addition, manual search of relevant reference did not identify any additional studies. At last, seven [12-18] randomized controlled trials (RCTs) were selected for this meta-analysis.
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3.2 Study characteristics participants Descriptive data for the RCTs in this meta-analysis were shown in Table 1. All of them were published between 2007 and 2017, involving 325 participants with a diagnosis of osteonecrosis of the femoral head. Experiential groups received fascia iliaca compartment block for postoperative pain management and control groups received placebo. The mean age ranged from 59-year-old to 81-year-old in FICB groups and 62-year-old to 82-year-old in control groups. Average follow up ranged from 1 week to 3 months.
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3.3 Risk of bias Cochrane Collaboration’s tool was adopted to assess the risk of bias. As shown in Table 2, five RCTs reported that participants were randomized with a computerized random number generator. Four RCTs showed that opaque, sealed envelope was used to make sure allocate concealment. Four studies performed double blinding. All RCTs provided complete outcome data. Other assessment of bias was unclear. Each risk of the bias item was expressed in terms of the percentage across all the included studies, which indicated the proportion of risk levels for each item bias (Table 3). 3.4 Outcome of meta-analysis 3.4.1 Pain score at 12 hour Seven studies compared the difference in the efficacy of FICB and placebo group on visual analogue score (VAS) at 12 hours. There was no significant heterogeneity 4
ACCEPTED MANUSCRIPT (P=0.081, I2=46.7%) and a fixed effect modal was used. The aggregated results of these studies suggest that FICB was associated with an improved VAS at 12 hour after THA (WMD=-0.285, 95% CI [-0.460, -0.109], P = 0.002, Figure. 2).
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3.4.2 Pain score at 24 hour Five RCTs reported the VAS at 24 hour after THA. A random effect modal was used because significant heterogeneity was found (P=0.013, I2=68.5%). The present meta-analysis indicated that there was significant difference between groups regarding the VAS at 24 hour (WMD=-0.391, 95% CI [-0.723, -0.059], P = 0.021, Figure. 3).
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3.4.3 Pain score at 48 hour A total of four RCTs showed the VAS at 48 hour after THA. There was significant heterogeneity and a random effect modal was adopted (P=0.002, I2=80.0%). Our meta-analysis demonstrated that there was no significant difference between groups regarding the VAS at 48 hour (WMD=-0.077, 95% CI [-0.169, 0.324], P = 0.538, Figure. 4).
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3.4.4 Opioid consumption at 12 hour Four studies compared the difference in the efficacy of FICB and placebo group on opioid consumption at 12 hour after THA. A random effect modal was adopted (P<0.001, I2=94.7%). The aggregated results of these studies suggest that FICB could significantly reduce opioid consumption at 12 hour (WMD=-5.394, 95% CI [-8.772, -2.016], P = 0.002, Figure. 5).
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3.4.5 Opioid consumption at 24 hour
Four RCTs involving 231 patients reported the opioid consumption at 24 hour. There is a high heterogeneity between the included studies (I2 = 89.3%, P<0.001). Compared with control group, FICB was associated with a significantly reduction of opioid consumption at 24 hour (WMD=-6.376, 95% CI [-10.737, -2.016], P = 0.004, Figure. 6). 3.4.6 Length of hospitalization Five RCTs provided the outcome of length of hospitalization after THA. No significant heterogeneity was identified in the pooled results, therefore a fixed-effects model was used (I2 = 0.6%, P=0.403). Our study demonstrated that there was no significant difference between groups (WMD= 0.112, 95% CI [-0.125, 0.350], P = 5
ACCEPTED MANUSCRIPT 0.354, Figure. 7).
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3.4.7 Incidence of complications A total of four RCTs showed the postoperative complications after THA. There was significant heterogeneity and a random effect modal was adopted (P=0.022, I2=50.6%). Our meta-analysis demonstrated that FICB could significantly reduce the occurrence of gastrointestinal reaction and did not increase the risk of falls (RD=-0.049, 95% CI [-0.096, -0.003], P = 0.037, Figure. 8).
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3.4.8 Publication bias and evidence level A low risk of publication bias was shown for the outcome of VAS at 12 hour (Table 4). However, publication bias was a limitation which existed in all meta-analysis. GRADE system was used to grading the evidence level. The overall evidence was moderate, which indicated that further research was likely to significantly alter confidence in the effect estimate and may change the estimate (Table 5).
4. Discussion
To the best of our knowledge, this is the first meta-analysis from RCTs to
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assess the efficacy and safety of FICB for pain control after THA. Our study indicated that FICB was associated with an improved pain relief and decreased opioid consumption. Additionally, FICB could significantly reduce the occurrence of gastrointestinal
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reaction and did not increase the risk of falls. The overall evidence was moderate, which indicated that further research was likely to significantly alter confidence in the
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effect estimate and may change the estimate. With the aging population, osteoarthritis (OA) is more and more common. It was reported that more than fifty million patients suffered from hip osteoarthritis in the USA. THA is the final choice to reduce pain and improve joint function. The annual workload of THA procedures were expected to reach 3.5 million by 2030. It has been a public health issue. Pain control is crucial for functional recovery and rehabilitation after THA. Optimal analgesia could reduce length of hospitalization and postoperative complications. Several analgesia methods have been tried for anesthesia and analgesia in hip replacement. Femoral nerve block is effective and easy to administer, and it can decrease the acute pain. Wiesmann et al [19] reported that single shot femoral nerve block for THA resulted in earlier post-operative care unit discharge capability, 6
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improved lung function during the first six hours and better pain control within the first 24 postoperative hours. Tetsunaga et al [20] demonstrated that there were no clinically significant differences in outcomes between femoral nerve block, epidural analgesia, patient-controlled analgesia after THA. However, some experts have shown that femoral nerve block was associated with a risk of femoral nerve injury and a potential for injury to the femoral vessels [21]. Recently, FICB was recommended and has been widely used for pain management after THA. FICB is an analgesic method which injects local anesthetic under the fascia of the iliacus muscle. It could be operated either guided by ultrasound or with a loss of resistance technique. Currently, the efficacy of safety of FICB for pain control after THA remains controversial due to the limited number of published studies and poor quality of current evidence. Although previous meta-analysis [22] has shown that FICB was effective in reducing pain after total knee replacement and total hip replacement, they were different surgical procedures and it could cause huge clinical heterogeneity. Therefore, we performed the meta-analysis from high quality RCTs and only THA was included. Seven RCTs with 325 patients showed the outcome of pain score. VAS (0-10 cm) was used for pain measurement after THA, and the present meta-analysis indicated that FICB was associated with a significantly reduction of VAS within the first 24 postoperative hours after THA. It was reported that approximately 30%-60% of patients suffered moderate to severe postoperative pain, especially within the first 24 hours after THA [23]. It has been well established that opioid is usually effective for pain relief, but often incurs side-effects that can prolong the length of hospitalization. Morphine, a mu-opioid receptor agonist, relieves pain by binding and activating the receptors in both the central and peripheral nervous systems [24]. As the most widely used narcotic for postoperative pain control, morphine has been reported a high incidence of adverse effects such as nausea, vomiting, headache, and urine retention, which could severely impede the postoperative convalescence [25, 26]. Besides, drug dependence is also a major concern. Thus, it was crucial to decrease opioid consumption so as to improve postoperative recovery. Peripheral nerve block was reported with a morphine-sparing effect and recommended by the UK National Institute of Health and Care Excellence [27]. FICB was operated to block the femoral nerve, the obturator nerve, and the lateral cutaneous nerves. Foss et al supported the use of FICB in acute management of hip fracture pain because it is an effective, easily learned procedure that also may reduce opioid side effects in this fragile, elderly group of patients. Watts et al [28] showed that FICB is as effective as femoral nerve block as part of a multimodal anesthetic regimen for total knee replacement. Currently, there was no reliable evidence regarding the morphine-sparing effect for FICB in THA. In our study, four RCTs provided the outcomes of morphine consumption and the present meta-analysis 7
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5. Conclusion
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indicated that FICB was associated with a significantly reduction of morphine consumption within the first 24 postoperative hours after THA. As is known to us all, intravenous morphine was associated with several side effects. Gastrointestinal reactions were the most common. Effective analgesia could reduce opioid consumption and then decrease the risk of opioids-related complications. A total of four RCTs showed the postoperative complications after THA. The overall incidence of nausea and vomiting is 7/109 in FICB groups compared 16/99 in controls. Our study indicated that the application of FICB could significantly reduce the risk of the postoperative complications. No dose-dependence analysis has been performed because only four RCTs were included and further investigation was still required. Theoretically, FICB increased the risk of fall because of the motor weakness. No significant difference was identified between groups. Several limitations should be acknowledged. Firstly, only seven study with small sample sizes were included and statistical tests may be insufficient. Secondly, publication bias is unavoidable because the identified language was restricted to English. Thirdly, some important outcomes, such as range of motion and functional score were not analyzed. Lastly, substantial heterogeneity was found in some results, which might affect the reliability.
Fascia iliaca compartment block are effective for pain relief during the early post-operative period after total hip arthroplasty. Meanwhile, it can reduce the
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cumulative morphine consumption and the risk of opioid-related adverse effects.
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Provenance and peer review Not commissioned, externally peer-reviewed
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Galakatos GR: Direct Anterior Total Hip Arthroplasty. Missouri medicine 2018, 115(6):537-541.
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Godoy Monzon D, Iserson KV, Jauregui J, Musso C, Piccaluga F, Buttaro M: Total hip arthroplasty for hip fractures: 5-year follow-up of functional outcomes in the oldest independent old and very old patients. Geriatric orthopaedic surgery & rehabilitation 2014, 5(1):3-8.
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Lehil MS, Bozic KJ: Trends in total hip arthroplasty implant utilization in the United States. The Journal of arthroplasty 2014, 29(10):1915-1918. 8
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total hip arthroplasty: a 12-year study. The bone & joint journal 2016, 98-B(5):585-588. 6.
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Pepe J, Madhani NB: Ultrasound-guided Fascia Iliaca Compartment Block. In: StatPearls. edn.
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Treasure Island (FL); 2018. 10.
Kaldirim U, Yolcu U: Fascia iliaca compartment block for hip dislocation. European journal of
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emergency medicine : official journal of the European Society for Emergency Medicine 2015, 22(2):145-146. 11.
Hsu YP, Hsu CW, Bai CH, Cheng SW, Chen C: Fascia iliaca compartment block versus intravenous analgesic for positioning of femur fracture patients before a spinal block: A PRISMA-compliant meta-analysis. Medicine 2018, 97(49):e13502.
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Stevens M, Harrison G, M: A modified fascia iliaca compartment block has significant morphine-sparing effect after total hip arthroplasty. Anaesthesia & Intensive Care 2007,
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Goitia Arrola L, Telletxea S, Martinez Bourio R, Arizaga Maguregui A, Aguirre Larracoechea U: [Fascia iliaca compartment block for analgesia following total hip replacement surgery]. Revista espanola de anestesiologia y reanimacion 2009, 56(6):343-348.
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Cucereanu Badica, Badica L, Barbilian R: The efficacy of fascia iliaca compartment block
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(FICB) for postoperative analgesia after hip arthroplasty (HA). Reg Anes Pain Med 2010, 35(5):E80. 15.
Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K,
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Vandepitte C, Gadsden J et al: Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Regional anesthesia and pain medicine
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Deniz S, Atim A, Kurklu M, Cayci T, Kurt E: Comparison of the postoperative analgesic efficacy of an ultrasound-guided fascia iliaca compartment block versus 3 in 1 block in hip prosthesis surgery. Agri : Agri 2014, 26(4):151-157.
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Bang S, Chung J, Jeong J, Bak H, Kim D: Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine 2016, 95(39):e5018.
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Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M: A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Regional anesthesia and pain medicine 2017, 42(3):327-333. 9
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Wiesmann T, Steinfeldt T, Wagner G, Wulf H, Schmitt J, Zoremba M: Supplemental single shot femoral nerve block for total hip arthroplasty: impact on early postoperative care, pain management and lung function. Minerva anestesiologica 2014, 80(1):48-57.
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Tetsunaga T, Sato T, Shiota N, Tetsunaga T, Yoshida M, Okazaki Y, Yamada K: Comparison of Continuous Epidural Analgesia, Patient-Controlled Analgesia with Morphine, and Continuous Three-in-One Femoral Nerve Block on Postoperative Outcomes after Total Hip Arthroplasty. Clinics in orthopedic surgery 2015, 7(2):164-170. Foisy K: Thou shalt not fall! Decreasing falls in the postoperative orthopedic patient with a
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femoral nerve block. Medsurg nursing : official journal of the Academy of Medical-Surgical Nurses 2013, 22(4):246-249. 22.
Zhang P, Li J, Song Y, Wang X: The efficiency and safety of fascia iliaca block for pain control after total joint arthroplasty: A meta-analysis. Medicine 2017, 96(15):e6592.
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Perioperative Pain Management: What Should Be in the Cocktail. JBJS reviews 2018, 6(12):e5. 24.
Weinsanto I, Mouheiche J, Laux-Biehlmann A, Delalande F, Marquette A, Chavant V, Gabel F,
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Cianferani S, Charlet A, Parat MO et al: Morphine Binds Creatine Kinase B and Inhibits Its Activity. Frontiers in cellular neuroscience 2018, 12:464. 25.
Eiselt E, Cote J, Longpre JM, Blais V, Sarret P, Gendron L: The combination of opioid and neurotensin receptor agonists improves their analgesic/adverse effect ratio. European journal of pharmacology 2019, 848:80-87.
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Oderda GM, Gan TJ, Johnson BH, Robinson SB: Effect of opioid-related adverse events on outcomes in selected surgical patients. Journal of pain & palliative care pharmacotherapy
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2013, 27(1):62-70.
Chesters A, Atkinson P: Fascia iliaca block for pain relief from proximal femoral fracture in the emergency department: a review of the literature. Emergency medicine journal : EMJ 2014, 31(e1):e84-87.
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Brisbane O, Sports Medicine Centre Writing C, McMeniman TJ, McMeniman PJ, Myers PT,
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Hayes DA, Cavdarski A, Wong MS, Wilson AJ, Jones MA et al: Femoral nerve block vs fascia iliaca block for total knee arthroplasty postoperative pain control: a prospective,
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randomized controlled trial. The Journal of arthroplasty 2010, 25(8):1246-1249.
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ACCEPTED MANUSCRIPT Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Blinding of outcome assessment (detection bias)
Selective reporting (reporting bias) Other bias
Low risk of bias
Unclear risk of bias
50%
High risk of bias
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Table 3 Risk of bias graph
25%
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0%
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Incomplete outcome data (attrition bias)
75%
100%
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No. of patients
Year
Design
Age
Study
Outcomes FICB
Control
FICB
Control
FICB
Follow up
Control
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Study
Gender (Male)
VAS 12-48h
Stevens et al
2007
RCT
THA
22
22
15
11
69
67
opioid consumption 12-24 hour
1 month
length of hospitalization
Deniz et al
Bang et al
2013
2014
2016
RCT
RCT
RCT
24
THA
30
THA
16
THA
THA
20
17
12
32
16
20
13
11
10
7
67
15
7
12
70
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RCT
THA
69
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Shariat et al
2010
RCT
EP
Badica et al
2009
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Arrola et al
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complications
8
12
61
72
57
VAS 12h
3 months
VAS 12h opioid consumption 12-24 hour
2 months
length of hospitalization
VAS 12-24h
2 weeks
length of hospitalization
VAS 12-48h 59
62
opioid consumption 12-24 hour length of hospitalization
1 week
complications
VAS 12-48h 5
2
81
82
length of hospitalization
1 week
complications
VAS 12-48h, Desmet et al
2017
RCT
THA
42
43
14
19
60
67
opioid consumption 12-24 hour complications
1 month
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Table 1 Characteristics of the included studies
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RCT: randomized controlled trial, TKA: total knee arthroplasty
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Blinding of participates and Random Sequence Generation
Blinding of outcome
Allocation Concealment
Selective Incomplete Outcome Data
personal
assessment
Other bias Reporting
Stevens
low risk
unclear risk
low risk
low risk
low risk
low risk
unclear risk
Arrola
low risk
low risk
low risk
low risk
low risk
low risk
unclear risk
Badica
unclear risk
unclear risk
unclear risk
low risk
low risk
low risk
Shariat
low risk
low risk
low risk
low risk
low risk
low risk
Deniz
unclear risk
high risk
unclear risk
unclear risk
low risk
low risk
Bang
low risk
low risk
low risk
low risk
low risk
low risk
Desmet
low risk
low risk
unclear risk
unclear risk
unclear risk
low risk
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Study
unclear risk
unclear risk
unclear risk
unclear risk
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unclear risk
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Table 2 Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias)
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Blinding of outcome assessment (detection bias) Incomplete outcome data (attrition bias)
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Selective reporting (reporting bias) Other bias 0% Low risk of bias
Unclear risk of bias
25%
50%
75%
100%
High risk of bias
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Table 3 Risk of bias graph
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SE(MD)
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0
0.1
0.3
0.4
MD
0
1
2
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Table 4 Publication bias for VAS at 12 hour
-1
EP
-2
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0.5
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0.2
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Quality assessment Limitations
Inconsistency
Indirectness
CRITICAL
WMD=-0.077, 95% CI [-0.169, 0.324]
moderate
CRITICAL
WMD=-5.394, 95% CI [-8.772, -2.016]
moderate
CRITICAL
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
RCT
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
WMD=-6.376, 95% CI [-10.737, -2.016]
moderate
CRITICAL
no serious limitations
no serious inconsistency
no serious indirectness
no serious limitations
WMD= 0.112, 95% CI [-0.125, 0.350]
high
IMPORTANT
no serious limitations
serious inconsistency
no serious indirectness
no serious limitations
RD=-0.049, 95% CI [-0.096, -0.003]
moderate
CRITICAL
no serious limitations
RCT
no serious limitations
RCT
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Table 5 The GRADE evidence quality
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RCT
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RCT
SC
RCT
Complications 4
moderate
no serious limitations
Length of hospitalization 5
WMD=-0.391, 95% CI [-0.723, -0.059]
no serious indirectness
Opioid consumption at 24 hour 4
CRITICAL
no serious inconsistency
Opioid consumption at 12 hour 4
high
no serious limitations
VAS at 48 4
WMD=-0.285, 95% CI [-0.460, -0.109]
RCT
VAS at 24 5
Importance
Imprecision
VAS at 12 7
Quality
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No of studies Design
Effect
Records identified through database searching (n =208)
Additional records identified through other sources (n = 0)
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Records screened (n =106)
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Full-text articles assessed for eligibility (n = 8)
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Included
Eligibility
Screening
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Records after duplicates removed (n =106)
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Identification
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Fig. 1 Flow chart of study selection
Studies included in qualitative synthesis (n = 7)
Studies included in quantitative synthesis (meta-analysis) (n = 7)
Irrelevant article (n=97) Case control study (n=1)
Full-text articles excluded for review studies (n = 1)
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Study
% WMD (95% CI)
Weight
Stevens (2007)
-1.10 (-2.03, -0.17)
3.54
Arrola (2009)
-0.30 (-1.00, 0.40)
6.22
Badica (2010)
-0.50 (-0.86, -0.14)
23.46
Shariat (2013)
0.50 (-0.33, 1.33)
4.46
-0.20 (-0.60, 0.20)
18.91
0.10 (-0.34, 0.54)
15.90
SC
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ID
Deniz (2014)
Desmet (2017) Overall (I-squared = 46.7%, p = 0.081)
-2.03
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Bang (2016)
0
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Fig. 2 Forest plot diagram of VAS at 12 hour
-0.40 (-0.73, -0.07)
27.51
-0.28 (-0.46, -0.11)
100.00
2.03
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Study
%
WMD (95% CI)
Weight
RI PT
ID
Stevens (2007)
Shariat (2013)
6.39
-0.30 (-0.90, 0.30)
16.10
-0.30 (-0.50, -0.10)
30.16
SC
Deniz (2014)
0.00 (-1.18, 1.18)
Bang (2016)
Overall (I-squared = 68.5%, p = 0.013)
NOTE: Weights are from random effects analysis -1.22
0
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Fig. 3 Forest plot diagram of VAS at 24 hour
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Desmet (2017)
-0.10 (-0.52, 0.32)
21.77
-0.90 (-1.22, -0.58)
25.57
-0.39 (-0.72, -0.06)
100.00
1.22
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Study
%
WMD (95% CI)
Weight
Stevens (2007)
0.00 (-0.59, 0.59)
11.67
SC
ID
Deniz (2014)
Desmet (2017)
Overall (I-squared = 80.0%, p = 0.002)
NOTE: Weights are from random effects analysis
0
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-.652
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Fig. 4 Forest plot diagram of VAS at 48 hour
29.43
0.40 (0.15, 0.65)
25.80
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Bang (2016)
-0.20 (-0.39, -0.01)
0.10 (-0.01, 0.21)
33.10
0.08 (-0.17, 0.32)
100.00
.652
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Study
%
WMD (95% CI)
Weight
-12.00 (-15.29, -8.71)
21.93
-6.20 (-8.70, -3.70)
24.05
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ID
Stevens (2007)
SC
Badica (2010)
Deniz (2014)
Overall (I-squared = 94.7%, p = 0.000)
NOTE: Weights are from random effects analysis
-15.3
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Desmet (2017)
0
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EP
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Fig. 5 Forest plot diagram of opioid consumption at 12 hour
-4.00 (-4.98, -3.02)
27.07
-0.70 (-1.77, 0.37)
26.95
-5.39 (-8.77, -2.02)
100.00
15.3
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%
RI PT
Study
WMD (95% CI)
Weight
Stevens (2007)
-17.00 (-22.50, -11.50)
20.09
Badica (2010)
-6.00 (-7.87, -4.13)
27.99
SC
ID
Deniz (2014)
Overall (I-squared = 89.3%, p = 0.000)
NOTE: Weights are from random effects analysis
-22.5
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Fig. 6 Forest plot diagram of opioid consumption at 24 hour
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-2.00 (-4.13, 0.13)
27.57
-6.38 (-10.74, -2.02)
0
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24.35
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Desmet (2017)
-3.00 (-6.70, 0.70)
22.5
100.00
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%
RI PT
Study
WMD (95% CI)
Weight
Stevens (2007)
-0.20 (-0.91, 0.51)
11.14
Badica (2010)
0.50 (0.03, 0.97)
25.03
0.00 (-0.35, 0.35)
45.17
0.20 (-0.58, 0.98)
9.38
SC
ID
Shariat (2013)
Bang (2016)
Overall (I-squared = 0.6%, p = 0.403)
0
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-.975
M AN U
Deniz (2014)
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Fig. 7 Forest plot diagram of length of hospitalization
-0.10 (-0.88, 0.68)
9.28
0.11 (-0.13, 0.35)
100.00
.975
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Study
% RD (95% CI)
Fall Stevens (2007) Deniz (2014) Bang (2016) Desmet (2017) Subtotal (I-squared = 0.0%, p = 0.793) .
0.04 (-0.07, 0.16)
9.39
0.00 (-0.09, 0.09)
14.28
0.03 (-0.05, 0.12)
15.83
0.00 (-0.04, 0.04)
60.50
0.01 (-0.03, 0.04)
100.00
SC
Nausea Stevens (2007) Deniz (2014) Bang (2016)
. Vomiting Stevens (2007) Deniz (2014) Bang (2016) Desmet (2017) Subtotal (I-squared = 0.0%, p = 0.822) .
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Overall (I-squared = 50.6%, p = 0.022)
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Desmet (2017) Subtotal (I-squared = 0.0%, p = 1.000)
-0.09 (-0.29, 0.11)
12.19
-0.10 (-0.32, 0.12)
10.26
-0.10 (-0.22, 0.02)
33.96
-0.09 (-0.20, 0.01)
43.58
-0.10 (-0.17, -0.03)
100.00
-0.18 (-0.35, -0.01)
15.61
-0.14 (-0.35, 0.06)
11.11
-0.10 (-0.22, 0.02)
32.10
-0.09 (-0.20, 0.01)
41.19
-0.11 (-0.18, -0.05)
100.00
-0.05 (-0.10, -0.00)
.
NOTE: Weights are from random effects analysis -.355
EP
Fig. 8 Forest plot diagram of postoperative complications
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Weight
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ID
0
.355
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Fascia iliaca compartment block was effective for pain relief after total hip arthroplasty.
Fascia iliaca compartment block reduced the cumulative morphine consumption.
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No increased risk of falls was related to fascia iliaca compartment block.
ACCEPTED MANUSCRIPT I confirm that the relevant data is real and you can get them by consulting
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correspondence author.