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Pain management after total knee arthroplasty: A prospective randomized study
Journal of Clinical Orthopaedics and Trauma xxx (xxxx) xxx
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Journal of Clinical Orthopaedics and Trauma journal homepage: www.elsevier.com/locate/jcot
Pain management after total knee arthroplasty: A prospective randomized study A. Paglia a, b, *, R. Goderecci a, b, N. Ciprietti a, b, M. Lagorio a, b, S. Necozione a, V. Calvisi a, b a b
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, Italy UOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
a r t i c l e i n f o
a b s t r a c t
Article history: Received 9 August 2018 Received in revised form 28 November 2018 Accepted 13 December 2018 Available online xxx
Introduction: Total knee arthroplasty (TKA) is a common procedure for improving mobility and quality of life in patients with osteoarthritis. Postoperative pain control management after TKA is still a concern as it relates to patients satisfaction and functional recovery. Many anesthetic regimens and techniques have been explored to decrease postoperative pain and enhance the fast recovery after TKA. The aim of this study was to evaluate the best anesthetic treatment in pain control after TKA. Methods: 51 patients were included in a randomized prospective study and distributed in three groups. The first group (CG) in which no analgesic protocol was implemented (control group). The second group (LIA group) received an intraoperative local infiltration anesthesia (LIA) (60 ml mixture of two ropivacaine 75mg/10 mL þ adrenaline 100mg/10 mL þ physiological solution). The third group (FNB group) had only a femoral nerve block (FNB). Continuous outcomes including visual analogue scale (VAS) at 5,24,48 h and at 1 week, morphine consumption and range of motion (ROM) at 1,2,7 days. Results: There was significant difference between all groups (p < 0,001) in terms of the VAS score: at 5h after surgery (4.55,2.15,1.82); at 24h (4.15,2.65,3.36); at 48h (3.85,2.45,2.73); at 1 week (2.95,1.80, 1.64), respectively for groups CG, LIA, FNB. ROM was better in LIA and FNB groups than CG: at 1 die after surgery (44 ,50 ,54 ); at 3 dies (69 ,70 ,71 ); at 7 dies (91,98 ,98 ), respectively for groups CG, LIA, FNB (p < 0,001). Discussion: LIA and FNB groups both showed a significant reduction at VAS score, better range of motion and less morphine consumption than CG (control group). LIA group has obtained a constant pain control in the postoperative days; FNB group had a good pain control in the hours after surgery, with a decrease in efficacy in the following days. Conclusion: Further studies are still needed in order to define LIA as the reference pain management in TKA. © 2018 Delhi Orthopedic Association. All rights reserved.
Keywords: Local infiltration anesthesia Total knee arthroplasty Femoral nerve block Postoperative pain control management
1. Background Total joint arthroplasty is one of the most successful surgical procedures. Management of pain following total joint arthroplasty is an important aspect of this procedure. The number of primary total knee arthroplasty (TKA) procedures will be reached at 3.48 million in 2030 in the United States.1 TKA was associated with moderate to severe postoperative pain. Adequate pain control allows faster rehabilitation2 and reduces the
* Corresponding author. Department of Life, Health & Environmental Sciences (MESVA), University of L'Aquila, Piazzale Tommasi 1, 67100, Coppito - L'Aquila, Italy. E-mail address: [email protected] (A. Paglia).
risk of postoperative complications.3 Pain control is also the most important component of patient satisfaction.4e6 Pain after TKA follows many specific characteristics: there is a higher occurrence during mobilization than at rest, the intensity usually peaks from 3 to 6 h after surgery and persists at least for 72 hours7 Achievement of pain relief is necessary and early pain control can increase patient satisfaction, reducing the length of hospitalisation.8,9 There are several methods available for postoperative analgesia management, including systemic opioids, epidural local anesthetics, peripheral nerve block, and local anesthetic infiltration analgesia. Parenteral opioids are associated with adverse effects including nausea, pruritus, and respiratory depression,10,11 and use of longacting intradural opioids has adverse effects such as bilateral
https://doi.org/10.1016/j.jcot.2018.12.005 0976-5662/© 2018 Delhi Orthopedic Association. All rights reserved.
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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A. Paglia et al. / Journal of Clinical Orthopaedics and Trauma xxx (xxxx) xxx
motor blockade, shivering, and hypotension.12e14 Local infiltration analgesia (LIA) and femoral nerve block (FNB) have shown better analgesia and less side effects. Many authors have shown that LIA provide improved pain relief compared with no injection,15e18 but the analgesic effect of LIA is connected with the ingredients of the cocktail. The goal of our study was to evaluate the best anesthetic treatment in pain control and functional outcomes after TKA. 2. Materials and methods 2.1. Study design This is a monocentric prospective, patient- and assessorblinded, randomized controlled clinical trial. All patients provided written informed consent. From January 2016 to July 2017 all patients undergoing primary TKA, in our hospital, were recruited. Exclusion criteria were: allergies to the drugs used in this study, neuromuscular disease, sensory disturbances of the legs, severe diabetes, heart failure, renal dysfunction, and liver dysfunction, chronic users of opioids or non-steroidal anti-inflammatory drugs (NSAIDs), a history of deep vein thrombosis, and previous knee surgery. Patients eligible for this study were randomized into three groups by sealed envelope. 2.2. Anesthetic, surgical techniques and postoperative care Spinal anesthesia was used for all patients. All operations were performed by a single senior surgeon implanting the same phrostetic model of cruciate retaining TKA and using a tourniquet. At the end of the surgery a wound drain was applied to all patients. After surgery, all patients were given enoxaparin 4000 UI for 2 week, 2g cefazolin twice for 3 days. Ketoprofen 160 mg/2 ml and oxycodonnaloxon 10/5 mg twice a day for a week were administered to all patients for pain control. Patients who received only this analgesic treatment represented the control group (CG). A second group of patients was treated adding a local infiltration anesthesia (LIA) to the baseline pain treatment (LIA group); specifically, a solution containing 20 ml of ropivacaine (150 mg of ropivacaine 7,5 mg/ml), 10 ml of adrenaline (1 mg ml1) and 30 ml of physiological solution was undertaken, by the surgeon, as follows: 40 ml administered into the posterior capsule, collateral ligaments, and quadriceps muscles before implant fixation; 20 ml administered subcutaneously around the skin incision before the wound closure; in all areas the procedure was performed sucking before the injection to avoid intravasal administration, and particular precaution has been used in the posterior capsule for the risks connected with neurovascular bundles, as the technique described by Dysart et al.19 A third group of patients was treated adding a femoral nerve block (FNB) to the baseline pain treatment (FNB group); the same anesthesiologist conducted one-shot FNB with 20 ml of chirocaine (10ml/5 mg) using an ultrasound-guided technique in combination with a nerve stimulus technique. If analgesia in all three groups was not sufficient and patients could not tolerate pain, oxycodon-naloxon dose was increased to 15/7,5 mg twice a day until discharge: patients were constantly monitored during all the time of hospital stay and basic therapy was immediately adapted for the control of algic symptoms. The wound drain was removed 24 h after the operation to all patients. All patients followed the same rehabilitation protocol: hamstring stretching after 8 h from surgery, weightbearing after 24 h from the surgery, walking and stairs climbing after 48 h from surgery; active and passive (through the use ok a kinetic device)
movements were started from the day after surgery for 25 min twice for a week. Maximum knee flexion angle was recorded by physiotherapists on post-operative days 1,2, and 7.
2.3. Outcome measures Self-reported pain at rest was assessed using VAS score (0 ¼ no pain; 10 ¼ worst pain), at 5, 24, 48 h and then 7 days after surgery. The blinded assessor recorded cases in which the dose of opioid drug was increased and all major complications, nausea, vomiting, and toxic symptoms of anesthetic drugs including dizziness, tinnitus, tongue numbness, neurapraxia and spasm. The passive knee range of motion (ROM) displayed in the kinetic device at 24,48 h and then 7 days after surgery, was also recorded by a blinded physioterhapist.
2.4. Statistics All continuous data of VAS and ROM were expressed as means and standard deviations of the mean. A two-factor analysis of variance (ANOVA) for repeated measures, after logarithmic transformation of variables in the event of non-normality of data, was performed to assess differences between groups. Chi-squared test was used to verify differences between groups for increasing dose of the opioid and for complications frequency. P-values less than 0.05 were taken as statistically significant. Statistical analysis was carried out using SAS System version 9.4 (SAS, Cary, NC, USA) and Med Calc statistical software version 13.3.1 (MedCalc Software bvba, Ostend, Belgium). The study has been based on an estimated sample size of 60 patients, with a ratio 1:1:1 for the 3 types of treatment (CG, LIA, FNB), which was calculated to be adequate to achieve 90% power to detect a medium effect size (Cohen's f: 0.25) with 2 df and an a of 0.05 on the VAS values between the 3 types of treatment. Statistical power has been assessed by G*POWER Version 3.1.9.2. Preoperative characteristics of all patients were evaluated through Kruskal-Wallis test except for Sex for which was used the Chi-squared test.
3. Results A total of 51 patients were successfully recruited: 20 patients were assigned to CG group, 20 patients to LIA group and 11 patients to FNB group. Demographic and clinical characteristics and mean tourniquet duration were similar in the 3 treatment groups and did not affected the following results (Table 1). Results of VAS score and ROM for each group are shown in the table below (Table 2; Figs. 1 and 2). In any case patients suffered of an intolerable pain and, if requested, the adjustment of baseline oral therapy was sufficient in every case to reduce the algic symptoms. No major adverse events and toxic symptoms of anesthetic drugs were described after surgery. For the first 24 h no patients asked or had so much pain discomfort to need an increased dose of opioid drug; after 48 h a higher dose of oxycodon-naloxon (15/7,5 mg) was necessary for 16, 4 and 2 patients of CG, LIA and FNB groups respectively (the chisquare test was 18.2373; p < 0,00011); of these patients 13, 3 and 1 patients of CG, LIA and FNB groups respectively suffered from nausea and/or vomiting (the chi-square test was 1.0029; p ¼ 0,60539). No patients of those that did not need an augmentation of opioid dose, suffered from gastrointestinal disorders.
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
A. Paglia et al. / Journal of Clinical Orthopaedics and Trauma xxx (xxxx) xxx
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Table 1 Baseline characteristics. Characteristic
GRUPPO A (CG) (n ¼ 20)
GRUPPO B (LIA) (n ¼ 20)
GRUPPO B (FNB) (n ¼ 11)
P value
Sex (M:F) Age (y) m (range) BMI m (range) ASA m ROM m min-max Tourniquet duration (min)
(8:12) 74.5 (60e91) 27.1 (23.5e36.7) 1.85 2.75e106.7 94.75
(5:15) 75.7 (52e84) 28.6 (23.5e36.8) 1.85 2.25e106 95
(4:7) 78.2 (70e84) 26.5 (24.2e28,4) 1.81 4.09e105 95
0.59 0.32 0.28 0.97 0.25 0.98
BMI: Body Mass Index, m: mean value, ROM: range of motion, ASA: American Score Anesthesiologists.
Table 2 VAS and ROM mean values for each group at each moment of follow-up and ANOVA p-values. VARIABLES
CONTROL GROUP
LIA GROUP
FNB GROUP
P value for Time
P value for Group x Time interaction
VAS 8 HOURS POST 24 HOURS POST 48 HOURS POST 7 DIE POST
4.45 ± 1.47 4.15 ± 2.01 3.85 ± 1.69 2.95 ± 1.19
2.15 ± 1.14 2.65 ± 1.46 2.45 ± 1.05 1.80 ± 0.95
1.82 ± 0.75 3.36 ± 1.36 2.73 ± 1.35 1.64 ± 0.69
P < 0,001
P < 0,001
PASSIVE ROM 24 HOURS POST 48 HOURS POST 7 DIE POST
44.00 ± 3.08 69.25 ± 5.91 91.75 ± 4.38
50.50 ± 4.56 70.00 ± 5.85 97.75 ± 7.86
54.09 ± 5.39 70.91 ± 6.64 98.18 ± 6.03
P < 0,001
P < 0,001
Fig. 1. Post-operative pain after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
4. Discussion There is debate in literature about the best method of postoperative pain management after TKA. The main objective of this study was to evaluate the best and safe anesthetic procedure between oral therapy, LIA and FNB in this type of surgery. The main findings of our study was that FNB was more effective than LIA in reducing pain immediately after surgery (within 8 h); however, FNB was less effective than LIA at 24 and 48 h after the surgery. There are two possible reasons for the lower analgesic effect of LIA immediately after the surgery. First, the anesthesiologist used an ultrasound guidance technique and nerve stimulation
equipment to carry out FNB, therefore accurate injection of the anesthetic agent to the femoral nerve was achieved. In comparison, the surgeons blindly injected the anesthetic agent to the sensory nerve at the rear of knee joint in the LIA group, which may result in variability among the analgesic effect of LIA. The second reason is that LIA was carried out during the surgery (before implant fixation and before wound closure), therefore the analgesic effect in LIA group might not have taken effect at the end of the surgery and at 8 h after surgery. Since the patients in LIA group expressed less pain than FNB group at 24 and 48 h after the surgery, LIA may have a longer acting time than FNB. Our results showed that both patients in LIA and FNB groups would experience enough reduction in pain
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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Fig. 2. Knee Range of motion (ROM) after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
after surgery than patients in control group. Our result is supported by a study comparing FNB and periarticular infiltration reporting that patients in the LIA group had a significantly lower visual analog scale score at rest 1 day after surgery than those in the continuous FNB group; the opioid consumption during the initial 24 h was significantly lower in the LIA group.20 Our results show that postoperative VAS score remained at a low level in LIA and FNB groups than the control group, and sufficient post-operative analgesia was achieved with either FNB or LIA technique. The time needed to perform FNB or LIA is also important to shorten the anesthetic time and to improve the efficiency of the operating room. LIA is an easy and fast technique, and surgeons can eliminate wasting time by injecting the drugs into the posterior of knee joint capsule while preparing the cement for implant fixation. Also, an accurate and fast FNB procedure was achieved using an ultrasound aided peripheral nerve stimulated technique, which offers the potential benefit of accelerating the procedure, reducing the dose of local anesthetics, and resulting in higher block success rates.21e24 Singh et al. comparing periarticular infiltration of liposomal bupivacaine to conventional analgesic regimens for total knee arthroplasty published till June 2016 were searched in medical database and concluded that liposomal bupivacaine infiltration has questionable clinical advantage, as it marginally shortens patient's hospital stay especially in comparison with patients receiving FNB; compared with conventional regimens, it can provide slightly superior yet sustained (till second postoperative day) perioperative analgesia; high heterogeneity suggests need for standardization of infiltration techniques for better predictability of results.25 Wang et al. recently reported that intraoperative periarticular liposomal bupivacaine infiltration, compared to standard bupivacaine, promotes superior pain relief and less morphine consumption after total knee arthroplasty; in addition, there were fewer side effects associated with liposomal bupivacaine infiltration.26 Liposomal bupivacaine, owing to its pharmacological properties of long duration of action should have logically demonstrated similar benefits over conventional periarticular local anes-thetic injections
as well. Carli et al.27 concluded that continuous FNB had better KSS and Western Ontario and McMaster Universities score than that of periarticular infiltration in their study. While study by Fan et al.28 showed no significant differences between LIA and FNB groups in terms of Visual Analogue Scale (VAS), Knee Society Score, and Range of Motion (ROM) before and after surgery. In our study, we found that FNB showed better ROM than group LIA on postoperative day 1 and showed similar ROM on post-operative days 2 and 7, which means there was no significant difference of patients knee function between LIA and FNB groups in the long term. The group of control showed less passive knee flexion angle than LIA and FNB groups on postoperative days 1, 2 and 7. The result was the same as those in the studies of Uesugi,29 Moghtadaei,30 and Carli.27 Finally, after 48 h of surgery, 16 patients of CG group (80%), 4 of LIA group (20%) and 2 of FNB group (18,2%), required an increase in oxycodon-naloxon dose to achieve good pain control. Of these patients (43,13%), 13 patients of CG group (65%), 3 of LIA group (15%) and 1 of FNB group (9,09%) had side effects like nausea and vomiting. Given that in patients who did not require an increase in oxycodone-naloxon dose, these effects were not observed, it can be inferred that the use of a single single oral therapy exposes more to the risk of a rescue dose with its consequent side effects. Problems for wound healing occasionally occurred in TKA surgeries, especially the cocktail used for local infiltration contains steroids. In our study used cocktail without steroids; muscles, fascia, and subcutaneous were sutured layer by layer. With good control of cocktail consumption and careful suture of incision, there were no wound healing problems in both groups. There are several limitations to be noted regarding this study. First of all there is an unequal distribution of patients in each group (20,20,11): the calculated power requested is to obtain a total of sixty patients but, since 10 patients were really dissatisfied for quadriceps weakness with difficulties in gait, active contraction, stair climbing and chair rising, we decided to evaluate if these side
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
A. Paglia et al. / Journal of Clinical Orthopaedics and Trauma xxx (xxxx) xxx
effects were connected to one specific treatment. We found that they were all assigned to envelope of FNB group. For this and ethical reasons, according to the anesthesiologists, we decided to interrupt this type of treatment excluding those sealed enveloped; the randomization was prosecuted and completed for CG and LIA groups. Another possible limitation of this study may be that each group received more than one drug to relieve pain, which synergistically influence patients pain level and affect the outcomes of VAS and morphine consumption. However, multimodal analgesia could reduce morphine consumption and get better pain control, which was advocated in clinic.31,32 Thirdly, randomization by sealed envelope is open to selection bias, and a better method would have been computer generated off-site randomization to reduce this bias. Fourthly, combining various implant models may have an unknown effect on postoperative pain and knee function. Fifthly, there is no standardization of injection technique. Finally, our study is a single-center clinic trial, and selective bias is unavoidable. So multicenter studies that are better planned are needed in the future.
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5. Conclusion 20.
Local infiltration analgesia is increasingly used in total knee arthroplasty in spite of relatively few positive randomized trials published so far.15,33e37 LIA provided a similar analgesic effect to the FNBs with a low incidence of complications, better postoperative pain relief and resulted in better inflammatory control without increasing complications. We recommend the use of LIA over the use of continuous FNB for pain relief after TKA. However, the combination of LIA and FNB could be an alternative way of anesthesia for TKA. Finally, in total knee arthroplasty, studies are required to define the major origin of pain, whether it is subcutaneous, capsular, anterior/posterior, to help implement effective treatment. Conflicts of interest Dr. Paglia Alessandro: None. Dr. Goderecci Remo: None. Dr. Ciprietti Norman: None. Dr. Lagorio Matteo: None. Prof. Necozione Stefano: None. Prof. Calvisi Vittorio: None.
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Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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Journal of Clinical Orthopaedics and Trauma journal homepage: www.elsevier.com/locate/jcot
Pain management after total knee arthroplasty: A prospective randomized study A. Paglia a, b, *, R. Goderecci a, b, N. Ciprietti a, b, M. Lagorio a, b, S. Necozione a, V. Calvisi a, b a b
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, Italy UOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
a r t i c l e i n f o
a b s t r a c t
Article history: Received 9 August 2018 Received in revised form 28 November 2018 Accepted 13 December 2018 Available online xxx
Introduction: Total knee arthroplasty (TKA) is a common procedure for improving mobility and quality of life in patients with osteoarthritis. Postoperative pain control management after TKA is still a concern as it relates to patients satisfaction and functional recovery. Many anesthetic regimens and techniques have been explored to decrease postoperative pain and enhance the fast recovery after TKA. The aim of this study was to evaluate the best anesthetic treatment in pain control after TKA. Methods: 51 patients were included in a randomized prospective study and distributed in three groups. The first group (CG) in which no analgesic protocol was implemented (control group). The second group (LIA group) received an intraoperative local infiltration anesthesia (LIA) (60 ml mixture of two ropivacaine 75mg/10 mL þ adrenaline 100mg/10 mL þ physiological solution). The third group (FNB group) had only a femoral nerve block (FNB). Continuous outcomes including visual analogue scale (VAS) at 5,24,48 h and at 1 week, morphine consumption and range of motion (ROM) at 1,2,7 days. Results: There was significant difference between all groups (p < 0,001) in terms of the VAS score: at 5h after surgery (4.55,2.15,1.82); at 24h (4.15,2.65,3.36); at 48h (3.85,2.45,2.73); at 1 week (2.95,1.80, 1.64), respectively for groups CG, LIA, FNB. ROM was better in LIA and FNB groups than CG: at 1 die after surgery (44 ,50 ,54 ); at 3 dies (69 ,70 ,71 ); at 7 dies (91,98 ,98 ), respectively for groups CG, LIA, FNB (p < 0,001). Discussion: LIA and FNB groups both showed a significant reduction at VAS score, better range of motion and less morphine consumption than CG (control group). LIA group has obtained a constant pain control in the postoperative days; FNB group had a good pain control in the hours after surgery, with a decrease in efficacy in the following days. Conclusion: Further studies are still needed in order to define LIA as the reference pain management in TKA. © 2018 Delhi Orthopedic Association. All rights reserved.
Keywords: Local infiltration anesthesia Total knee arthroplasty Femoral nerve block Postoperative pain control management
1. Background Total joint arthroplasty is one of the most successful surgical procedures. Management of pain following total joint arthroplasty is an important aspect of this procedure. The number of primary total knee arthroplasty (TKA) procedures will be reached at 3.48 million in 2030 in the United States.1 TKA was associated with moderate to severe postoperative pain. Adequate pain control allows faster rehabilitation2 and reduces the
* Corresponding author. Department of Life, Health & Environmental Sciences (MESVA), University of L'Aquila, Piazzale Tommasi 1, 67100, Coppito - L'Aquila, Italy. E-mail address: [email protected] (A. Paglia).
risk of postoperative complications.3 Pain control is also the most important component of patient satisfaction.4e6 Pain after TKA follows many specific characteristics: there is a higher occurrence during mobilization than at rest, the intensity usually peaks from 3 to 6 h after surgery and persists at least for 72 hours7 Achievement of pain relief is necessary and early pain control can increase patient satisfaction, reducing the length of hospitalisation.8,9 There are several methods available for postoperative analgesia management, including systemic opioids, epidural local anesthetics, peripheral nerve block, and local anesthetic infiltration analgesia. Parenteral opioids are associated with adverse effects including nausea, pruritus, and respiratory depression,10,11 and use of longacting intradural opioids has adverse effects such as bilateral
https://doi.org/10.1016/j.jcot.2018.12.005 0976-5662/© 2018 Delhi Orthopedic Association. All rights reserved.
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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motor blockade, shivering, and hypotension.12e14 Local infiltration analgesia (LIA) and femoral nerve block (FNB) have shown better analgesia and less side effects. Many authors have shown that LIA provide improved pain relief compared with no injection,15e18 but the analgesic effect of LIA is connected with the ingredients of the cocktail. The goal of our study was to evaluate the best anesthetic treatment in pain control and functional outcomes after TKA. 2. Materials and methods 2.1. Study design This is a monocentric prospective, patient- and assessorblinded, randomized controlled clinical trial. All patients provided written informed consent. From January 2016 to July 2017 all patients undergoing primary TKA, in our hospital, were recruited. Exclusion criteria were: allergies to the drugs used in this study, neuromuscular disease, sensory disturbances of the legs, severe diabetes, heart failure, renal dysfunction, and liver dysfunction, chronic users of opioids or non-steroidal anti-inflammatory drugs (NSAIDs), a history of deep vein thrombosis, and previous knee surgery. Patients eligible for this study were randomized into three groups by sealed envelope. 2.2. Anesthetic, surgical techniques and postoperative care Spinal anesthesia was used for all patients. All operations were performed by a single senior surgeon implanting the same phrostetic model of cruciate retaining TKA and using a tourniquet. At the end of the surgery a wound drain was applied to all patients. After surgery, all patients were given enoxaparin 4000 UI for 2 week, 2g cefazolin twice for 3 days. Ketoprofen 160 mg/2 ml and oxycodonnaloxon 10/5 mg twice a day for a week were administered to all patients for pain control. Patients who received only this analgesic treatment represented the control group (CG). A second group of patients was treated adding a local infiltration anesthesia (LIA) to the baseline pain treatment (LIA group); specifically, a solution containing 20 ml of ropivacaine (150 mg of ropivacaine 7,5 mg/ml), 10 ml of adrenaline (1 mg ml1) and 30 ml of physiological solution was undertaken, by the surgeon, as follows: 40 ml administered into the posterior capsule, collateral ligaments, and quadriceps muscles before implant fixation; 20 ml administered subcutaneously around the skin incision before the wound closure; in all areas the procedure was performed sucking before the injection to avoid intravasal administration, and particular precaution has been used in the posterior capsule for the risks connected with neurovascular bundles, as the technique described by Dysart et al.19 A third group of patients was treated adding a femoral nerve block (FNB) to the baseline pain treatment (FNB group); the same anesthesiologist conducted one-shot FNB with 20 ml of chirocaine (10ml/5 mg) using an ultrasound-guided technique in combination with a nerve stimulus technique. If analgesia in all three groups was not sufficient and patients could not tolerate pain, oxycodon-naloxon dose was increased to 15/7,5 mg twice a day until discharge: patients were constantly monitored during all the time of hospital stay and basic therapy was immediately adapted for the control of algic symptoms. The wound drain was removed 24 h after the operation to all patients. All patients followed the same rehabilitation protocol: hamstring stretching after 8 h from surgery, weightbearing after 24 h from the surgery, walking and stairs climbing after 48 h from surgery; active and passive (through the use ok a kinetic device)
movements were started from the day after surgery for 25 min twice for a week. Maximum knee flexion angle was recorded by physiotherapists on post-operative days 1,2, and 7.
2.3. Outcome measures Self-reported pain at rest was assessed using VAS score (0 ¼ no pain; 10 ¼ worst pain), at 5, 24, 48 h and then 7 days after surgery. The blinded assessor recorded cases in which the dose of opioid drug was increased and all major complications, nausea, vomiting, and toxic symptoms of anesthetic drugs including dizziness, tinnitus, tongue numbness, neurapraxia and spasm. The passive knee range of motion (ROM) displayed in the kinetic device at 24,48 h and then 7 days after surgery, was also recorded by a blinded physioterhapist.
2.4. Statistics All continuous data of VAS and ROM were expressed as means and standard deviations of the mean. A two-factor analysis of variance (ANOVA) for repeated measures, after logarithmic transformation of variables in the event of non-normality of data, was performed to assess differences between groups. Chi-squared test was used to verify differences between groups for increasing dose of the opioid and for complications frequency. P-values less than 0.05 were taken as statistically significant. Statistical analysis was carried out using SAS System version 9.4 (SAS, Cary, NC, USA) and Med Calc statistical software version 13.3.1 (MedCalc Software bvba, Ostend, Belgium). The study has been based on an estimated sample size of 60 patients, with a ratio 1:1:1 for the 3 types of treatment (CG, LIA, FNB), which was calculated to be adequate to achieve 90% power to detect a medium effect size (Cohen's f: 0.25) with 2 df and an a of 0.05 on the VAS values between the 3 types of treatment. Statistical power has been assessed by G*POWER Version 3.1.9.2. Preoperative characteristics of all patients were evaluated through Kruskal-Wallis test except for Sex for which was used the Chi-squared test.
3. Results A total of 51 patients were successfully recruited: 20 patients were assigned to CG group, 20 patients to LIA group and 11 patients to FNB group. Demographic and clinical characteristics and mean tourniquet duration were similar in the 3 treatment groups and did not affected the following results (Table 1). Results of VAS score and ROM for each group are shown in the table below (Table 2; Figs. 1 and 2). In any case patients suffered of an intolerable pain and, if requested, the adjustment of baseline oral therapy was sufficient in every case to reduce the algic symptoms. No major adverse events and toxic symptoms of anesthetic drugs were described after surgery. For the first 24 h no patients asked or had so much pain discomfort to need an increased dose of opioid drug; after 48 h a higher dose of oxycodon-naloxon (15/7,5 mg) was necessary for 16, 4 and 2 patients of CG, LIA and FNB groups respectively (the chisquare test was 18.2373; p < 0,00011); of these patients 13, 3 and 1 patients of CG, LIA and FNB groups respectively suffered from nausea and/or vomiting (the chi-square test was 1.0029; p ¼ 0,60539). No patients of those that did not need an augmentation of opioid dose, suffered from gastrointestinal disorders.
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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Table 1 Baseline characteristics. Characteristic
GRUPPO A (CG) (n ¼ 20)
GRUPPO B (LIA) (n ¼ 20)
GRUPPO B (FNB) (n ¼ 11)
P value
Sex (M:F) Age (y) m (range) BMI m (range) ASA m ROM m min-max Tourniquet duration (min)
(8:12) 74.5 (60e91) 27.1 (23.5e36.7) 1.85 2.75e106.7 94.75
(5:15) 75.7 (52e84) 28.6 (23.5e36.8) 1.85 2.25e106 95
(4:7) 78.2 (70e84) 26.5 (24.2e28,4) 1.81 4.09e105 95
0.59 0.32 0.28 0.97 0.25 0.98
BMI: Body Mass Index, m: mean value, ROM: range of motion, ASA: American Score Anesthesiologists.
Table 2 VAS and ROM mean values for each group at each moment of follow-up and ANOVA p-values. VARIABLES
CONTROL GROUP
LIA GROUP
FNB GROUP
P value for Time
P value for Group x Time interaction
VAS 8 HOURS POST 24 HOURS POST 48 HOURS POST 7 DIE POST
4.45 ± 1.47 4.15 ± 2.01 3.85 ± 1.69 2.95 ± 1.19
2.15 ± 1.14 2.65 ± 1.46 2.45 ± 1.05 1.80 ± 0.95
1.82 ± 0.75 3.36 ± 1.36 2.73 ± 1.35 1.64 ± 0.69
P < 0,001
P < 0,001
PASSIVE ROM 24 HOURS POST 48 HOURS POST 7 DIE POST
44.00 ± 3.08 69.25 ± 5.91 91.75 ± 4.38
50.50 ± 4.56 70.00 ± 5.85 97.75 ± 7.86
54.09 ± 5.39 70.91 ± 6.64 98.18 ± 6.03
P < 0,001
P < 0,001
Fig. 1. Post-operative pain after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
4. Discussion There is debate in literature about the best method of postoperative pain management after TKA. The main objective of this study was to evaluate the best and safe anesthetic procedure between oral therapy, LIA and FNB in this type of surgery. The main findings of our study was that FNB was more effective than LIA in reducing pain immediately after surgery (within 8 h); however, FNB was less effective than LIA at 24 and 48 h after the surgery. There are two possible reasons for the lower analgesic effect of LIA immediately after the surgery. First, the anesthesiologist used an ultrasound guidance technique and nerve stimulation
equipment to carry out FNB, therefore accurate injection of the anesthetic agent to the femoral nerve was achieved. In comparison, the surgeons blindly injected the anesthetic agent to the sensory nerve at the rear of knee joint in the LIA group, which may result in variability among the analgesic effect of LIA. The second reason is that LIA was carried out during the surgery (before implant fixation and before wound closure), therefore the analgesic effect in LIA group might not have taken effect at the end of the surgery and at 8 h after surgery. Since the patients in LIA group expressed less pain than FNB group at 24 and 48 h after the surgery, LIA may have a longer acting time than FNB. Our results showed that both patients in LIA and FNB groups would experience enough reduction in pain
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
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Fig. 2. Knee Range of motion (ROM) after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
after surgery than patients in control group. Our result is supported by a study comparing FNB and periarticular infiltration reporting that patients in the LIA group had a significantly lower visual analog scale score at rest 1 day after surgery than those in the continuous FNB group; the opioid consumption during the initial 24 h was significantly lower in the LIA group.20 Our results show that postoperative VAS score remained at a low level in LIA and FNB groups than the control group, and sufficient post-operative analgesia was achieved with either FNB or LIA technique. The time needed to perform FNB or LIA is also important to shorten the anesthetic time and to improve the efficiency of the operating room. LIA is an easy and fast technique, and surgeons can eliminate wasting time by injecting the drugs into the posterior of knee joint capsule while preparing the cement for implant fixation. Also, an accurate and fast FNB procedure was achieved using an ultrasound aided peripheral nerve stimulated technique, which offers the potential benefit of accelerating the procedure, reducing the dose of local anesthetics, and resulting in higher block success rates.21e24 Singh et al. comparing periarticular infiltration of liposomal bupivacaine to conventional analgesic regimens for total knee arthroplasty published till June 2016 were searched in medical database and concluded that liposomal bupivacaine infiltration has questionable clinical advantage, as it marginally shortens patient's hospital stay especially in comparison with patients receiving FNB; compared with conventional regimens, it can provide slightly superior yet sustained (till second postoperative day) perioperative analgesia; high heterogeneity suggests need for standardization of infiltration techniques for better predictability of results.25 Wang et al. recently reported that intraoperative periarticular liposomal bupivacaine infiltration, compared to standard bupivacaine, promotes superior pain relief and less morphine consumption after total knee arthroplasty; in addition, there were fewer side effects associated with liposomal bupivacaine infiltration.26 Liposomal bupivacaine, owing to its pharmacological properties of long duration of action should have logically demonstrated similar benefits over conventional periarticular local anes-thetic injections
as well. Carli et al.27 concluded that continuous FNB had better KSS and Western Ontario and McMaster Universities score than that of periarticular infiltration in their study. While study by Fan et al.28 showed no significant differences between LIA and FNB groups in terms of Visual Analogue Scale (VAS), Knee Society Score, and Range of Motion (ROM) before and after surgery. In our study, we found that FNB showed better ROM than group LIA on postoperative day 1 and showed similar ROM on post-operative days 2 and 7, which means there was no significant difference of patients knee function between LIA and FNB groups in the long term. The group of control showed less passive knee flexion angle than LIA and FNB groups on postoperative days 1, 2 and 7. The result was the same as those in the studies of Uesugi,29 Moghtadaei,30 and Carli.27 Finally, after 48 h of surgery, 16 patients of CG group (80%), 4 of LIA group (20%) and 2 of FNB group (18,2%), required an increase in oxycodon-naloxon dose to achieve good pain control. Of these patients (43,13%), 13 patients of CG group (65%), 3 of LIA group (15%) and 1 of FNB group (9,09%) had side effects like nausea and vomiting. Given that in patients who did not require an increase in oxycodone-naloxon dose, these effects were not observed, it can be inferred that the use of a single single oral therapy exposes more to the risk of a rescue dose with its consequent side effects. Problems for wound healing occasionally occurred in TKA surgeries, especially the cocktail used for local infiltration contains steroids. In our study used cocktail without steroids; muscles, fascia, and subcutaneous were sutured layer by layer. With good control of cocktail consumption and careful suture of incision, there were no wound healing problems in both groups. There are several limitations to be noted regarding this study. First of all there is an unequal distribution of patients in each group (20,20,11): the calculated power requested is to obtain a total of sixty patients but, since 10 patients were really dissatisfied for quadriceps weakness with difficulties in gait, active contraction, stair climbing and chair rising, we decided to evaluate if these side
Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005
A. Paglia et al. / Journal of Clinical Orthopaedics and Trauma xxx (xxxx) xxx
effects were connected to one specific treatment. We found that they were all assigned to envelope of FNB group. For this and ethical reasons, according to the anesthesiologists, we decided to interrupt this type of treatment excluding those sealed enveloped; the randomization was prosecuted and completed for CG and LIA groups. Another possible limitation of this study may be that each group received more than one drug to relieve pain, which synergistically influence patients pain level and affect the outcomes of VAS and morphine consumption. However, multimodal analgesia could reduce morphine consumption and get better pain control, which was advocated in clinic.31,32 Thirdly, randomization by sealed envelope is open to selection bias, and a better method would have been computer generated off-site randomization to reduce this bias. Fourthly, combining various implant models may have an unknown effect on postoperative pain and knee function. Fifthly, there is no standardization of injection technique. Finally, our study is a single-center clinic trial, and selective bias is unavoidable. So multicenter studies that are better planned are needed in the future.
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5. Conclusion 20.
Local infiltration analgesia is increasingly used in total knee arthroplasty in spite of relatively few positive randomized trials published so far.15,33e37 LIA provided a similar analgesic effect to the FNBs with a low incidence of complications, better postoperative pain relief and resulted in better inflammatory control without increasing complications. We recommend the use of LIA over the use of continuous FNB for pain relief after TKA. However, the combination of LIA and FNB could be an alternative way of anesthesia for TKA. Finally, in total knee arthroplasty, studies are required to define the major origin of pain, whether it is subcutaneous, capsular, anterior/posterior, to help implement effective treatment. Conflicts of interest Dr. Paglia Alessandro: None. Dr. Goderecci Remo: None. Dr. Ciprietti Norman: None. Dr. Lagorio Matteo: None. Prof. Necozione Stefano: None. Prof. Calvisi Vittorio: None.
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Please cite this article as: Paglia A et al., Pain management after total knee arthroplasty: A prospective randomized study, Journal of Clinical Orthopaedics and Trauma, https://doi.org/10.1016/j.jcot.2018.12.005