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Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for Same-Day Bilateral Total Knee Arthroplasty
The Journal of Arthroplasty xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for Same-Day Bilateral Total Knee Arthroplasty Nimit Patel, MD b, Olga Solovyova, MD c, Greg Matthews, MS d, Sivasenthil Arumugam, MD e, Sanjay K. Sinha, MD e, Courtland G. Lewis, MD a a
Connecticut Joint Replacement Institute, Saint Francis Hospital, Hartford, CT Drexel Orthopaedics, Philadelphia, PA c NYU Hospital for Joint Disease, New York, NY d Department of Statistics, Storrs, CT e Woodland Anesthesiology Associates, Hartford, CT b
a r t i c l e
i n f o
Article history: Received 31 August 2011 Accepted 17 September 2014 Available online xxxx Keywords: bilateral total knee same-day peripheral nerve block epidural safety
a b s t r a c t In a retrospective analysis, we evaluated the safety and efficacy of peripheral nerve blocks (PNB) compared to epidural anesthesia in 221 consecutive patients undergoing same-day bilateral total knee arthroplasty (TKA). Primary outcome measures included: hypotension requiring physician intervention, number of blood transfusions, perioperative hespan and crystalloid consumption, incidences of respiratory desaturation, pruritis, urinary retention, and nausea/vomiting. The incidences of hypotension, urinary retention, and pruritis were all higher in the epidural group, compared to PNB. Epidural patients also required more blood transfusions and greater volumes of hespan and crystalloid. PNB are safe and efficacious modality of analgesia for same day bilateral TKA and provide adequate pain relief with a significant decrease in postoperative complications compared to epidural anesthesia. © 2014 Elsevier Inc. All rights reserved.
Total knee arthroplasty (TKA) is a commonly used and successful procedure for the treatment of degenerative diseases of the knee joint [1]. The surgery, however, results in significant postoperative pain [2–4]. Good analgesia is essential for patient satisfaction and postoperative rehabilitation. There are a number of frequently used analgesic techniques that provide satisfactory pain relief but are also associated with adverse side effects. For example, opioid drugs can result in nausea, vomiting, hypotension, respiratory depression, urinary retention, sedation, pruritus, reduced gut motility, and confusion [2,4–6]. Current techniques in pain management following TKA include the use of parenteral opioids, epidural analgesia, and peripheral nerve blocks (PNB). The ongoing goal in the fields of anesthesia and surgery is to provide a combination of reliable analgesia while minimizing adverse side effects, thereby improving patient outcome and satisfaction. Epidural anesthesia has been popular over the recent decades and has claimed to provide comparable pain relief to general anesthesia with fewer systemic side effects in TKA [7,8]. Recently, in a metaanalysis, Hu et al identified 21 independent randomized clinical trials designed to evaluate the relative efficacy of regional and general The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2014.09.015. Reprint requests: Courtland G. Lewis, MD, Orthopaedic Associates of Hartford, 85 Seymour St., Hartford, CT 06102.
anesthesia in patients undergoing total hip or knee arthroplasty. They concluded that regional anesthesia reduced the duration of surgery, incidence of post-operative nausea and vomiting, and the development of thromboembolic disease (deep-vein thrombosis and pulmonary embolism) [9]. Another randomized controlled trial reported a 50% reduction in blood transfusion requirements, further substantiating the efficacy of regional anesthetic techniques compared to general anesthesia [10]. Despite these benefits of epidural anesthesia, it was not without side effects. A number of publications have shown that the technique may cause epidural hematomas, urinary retention, spinal headache, hypotension, motor weakness, and hemodynamic instability from the sympathectomy [5,6,11]. Until recently, regional anesthetic techniques have largely been epidural or spinal procedures [12]. However, PNB have been shown to reduce the side effects associated with the aforementioned treatments while providing satisfactory pain management and improved muscle control. Three different meta-analyses, comparing systemic opioids, epidural anesthesia, and continuous PNB in randomized controlled trials, have all demonstrated comparable analgesia with a significantly lower incidence of hypotension [13,14]. Several larger observational studies comparing PNB with epidural anesthesia for lower limb surgery are also consistent with the results of the meta-analyses [15–17]. Likewise, in a cohort study of 92 patients, comparing patient controlled analgesia (PCA) morphine, continuous femoral with single shot sciatic
http://dx.doi.org/10.1016/j.arth.2014.09.015 0883-5403/© 2014 Elsevier Inc. All rights reserved.
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
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N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
block, and epidural analgesia in patients undergoing TKA, the patients in the PNB group had improved pain control, decreased incidence of cardiovascular instability, and a reduction in nausea and vomiting compared with those who had epidurals or PCA [18]. As a result of good analgesia and improved muscle control, PNBs may allow for faster mobilization of the patient and shorter hospital stay, thereby possibly reducing the risk of nosocomial infection and deep vein thrombosis. Even though combined femoral-sciatic blocks are routinely used as part of multimodal post-operative pain control after unilateral TKA, epidural and spinal anesthesia are commonly used for patients undergoing bilateral TKA. There is a paucity of data regarding the use of PNB in patients undergoing bilateral TKA. We performed a retrospective analysis comparing epidural anesthesia to combined femoral-sciatic nerve block as part of a multimodal therapy program in patients undergoing bilateral, same-day total knee arthroplasty. Materials and Methods Patients The study was conducted at a high volume joint arthroplasty center after receiving approval from the Institutional Review Board (IRB# 09-07-002). We identified 221 consecutive patients who underwent elective sequential (same day) bilateral TKA from 11/1/06 to 10/31/08 from our operative registry. Prior to 2008, the majority of patients received epidurals as standard of care. At that time, the center switched over to PNB for same day bilateral TKAs. The dates for the study were chosen so as to capture a similar number of patients for each study group. Patients were excluded if they had undergone knee revision surgery or had contraindications to regional anesthesia. Specific contraindications to regional nerve blocks include: patient refusal, local infection at the injection site, allergy to local anesthetics, bleeding disorder that carried increased risk for developing hematomas, and preexisting neuropathy. Patients who received their catheter and blocks after surgery were excluded; only patients with preoperative catheter placements were included. Patients who received epidurals combined with peripheral nerve blocks for perioperative analgesia were identified and excluded. All patients receiving PNB were given a standard premedication consisting of Celebrex 200 mg BID, pregablin 50 mg, and acetaminophen which were continued for the rest of their hospital stay. In addition, Oxycontin was added to the postoperative pain therapy. These patients were also eligible to receive oxycodone or iv hydromorphone for breakthrough pain, if needed. All patients received DVT prophylaxis with Coumadin, Lovenox, or heparin postoperatively based on surgeon preference. Patients received Coumadin for 1 month with an INR goal of 1.8–2.3 due to increased concerns of bleeding. The remaining patients, minus one, received Lovenox for 10 days followed by aspirin for 6 weeks postoperatively. Heparin was used in one patient in our study due to surgeon preference. Anesthetic Technique PNB were placed with the patient supine, under strict sterile preparation and precautions. Ultrasound guided placement of continuous femoral nerve block was performed (18G Tuohy needle and stimulating catheter) with the catheter about 5 to 6 cm beyond the needle tip, and a bolus dose of 0.2% ropivacaine was administered. After securing the catheter, the patient was turned lateral with the side to be blocked superior. Again, under sterile preparation and precautions, a single dose sciatic nerve block was performed at the lower posterior thigh with 0.2% ropivacaine. The same technique was done to the contralateral side. All patients received laryngeal mask airway general anesthesia for surgery. On average, patients received 14 ± 2.0 cc and 14 ± 1.9 cc of ropivacaine for both left and right femoral nerves respectively, and 14 ± 2.1 cc and 14 ± 2.2 cc of ropivacaine for both left and
right sciatic nerve blocks respectively. All PNB were discontinued and catheters removed by 6 AM on post operative day 2. In the epidural group, blocks were placed with the patient either sitting up or lying in the lateral decubitus position, under strict sterile preparation and precautions. The L3-4 or L2-3 interspace was identified and infiltrated locally with 1% lidocaine. Upon identification of the epidural space with loss of resistance, using an 18G Tuohy needle, an epidural catheter was inserted (usually 4 to 5 cm in epidural space), secured in place, and a test dose (3 cc of 1.5% lidocaine with epinephrine) was administered. Following this, a bolus dose of 0.25% bupivacaine was administered. The patient was then taken to the operating room and received general anesthesia. Patients in the epidural group on average received a 12 ± 4.4 cc bolus of bupivacaine. All patients received laryngeal mask anesthesia and IV sedation for surgery. All epidural catheters were removed on postoperative day two. Outcome Measures Outcome measures included: (i) adverse effects: hypotension requiring physician intervention (a 25% or greater fall in systolic blood pressure), number of blood transfusions, perioperative hespan and crystalloid consumption, incidences of respiratory desaturation (any incidence of saturation below 95%), pruritis, urinary retention, and nausea and vomiting; (ii) analgesic efficacy: the number of physician interventions for postoperative pain control. We also report other secondary outcome data, including length of stay, patient falls, cardiac complications, pulmonary emboli, and residual peripheral nerve damage. As the majority of the cases were performed by one surgeon, a subanalysis of his patient cohort was conducted. Twenty-eight PNB patients were compared to 102 epidural patients. The same outcome measures were used for the subanalysis. The subanalysis data are included in the supplement to this paper. Statistical Methods All statistical analysis was conducted using SAS Software (SAS Institute Inc, Cary, NC). Several modeling strategies were employed on the basis of the type of data generated for a given side effect. For those that generated binary data (a patient either experiences the given side effect or does not) logistic regression was used. For count and continuous data, negative binomial regression was used. All models were first built using all of the available data for the overall analysis. Subsequently, just the data for the surgeon who performed the majority of the procedures were used to build the models a second time. For each side effect, a model was built controlling for gender, age, BMI, ASA score, and DVT prophylaxis (Coumadin or Lovenox). ASA score was used to create an indicator variable with a high level (ASA = 3 or 4) and a low level (ASA = 1 or 2). P-values, odds ratios, and 95% confidence intervals were calculated for the binary data. P-values and parameter estimates were calculated for the count and continuous data. Source of Funding No external funding was received for this study. Results From 11/1/06 to 10/31/08 there were 221 patients who had bilateral total knee arthroplasties performed at our institution. Of these patients, only 187 were included in the analysis; 127 of them had epidural and 60 had PNB. The remaining 34 patients were not included in the study as they had PCA or a combination of epidural with single injection femoral nerve block for postoperative management. Table 1 shows that there were no differences in patient characteristics. The average ages were 65.7 ± 10.3 and 65.9 ± 8.6 in the epidural and PNB groups, respectively. The ratio of men to women was also comparable, with 73 (57.5%)
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Discussion
Table 1 Preoperative Demographic Data and Length of Stay. Peripheral Nerve Block (n = 127)
Epidural (n = 60)
Age (years) Height (in) Weight (lbs) BMI LOS (days)
Mean
SD
Mean
SD
65.7 65.7 202.7 32.9 3.3
10.3 4.0 43.0 6.2 0.8
65.9 67.4 199.2 30.9 3.5
8.6 3.8 31.6 5.1 2.3
women and 54 (42.5%) men in the epidural group and 33 (55.0%) women and 27 (45.0%) men in the PNB group. None of the preoperative measurements were statistically significant including height (epidural = 65.7 ± 4.0, PNB = 67.4 ± 3.8), weight (epidural = 202.7 ± 43.0, PNB = 199.2 ± 31.6), and body mass index (epidural = 32.9 ± 6.2, PNB = 30.9 ± 5.1). Additionally, the ASA scores were mostly 2 and 3 for both groups; there was no statistically significant difference between the groups. Figs. 1 and 2 show the results of our primary and secondary outcome measures. There were no significant differences between the two groups for the level of pain in the PACU; on a scale of 0 to 10 (0 being no pain and 10 being the worst pain ever felt). Epidurals had a median PACU pain score of 3 and PNB had a median score of 1. The number of physician interventions required to manage postoperative pain prior to PACU discharge was similar between the groups, as was the narcotic consumption. However, the rate of hypotension which required physician intervention was higher in the epidural group (0.40 vs 0.17, P = 0.0099). Patients who had received epidurals also required a greater number of PACU blood transfusions (0.6 ± 1.0 vs 0.2 ± 0.4 units/patient, P = 0.0061) and post PACU discharge blood transfusions (2.0 ± 1.4 vs 1.3 ± 1.3 units/patient, P = 0.0037). The parameter estimate for PACU and post PACU blood transfusions was 1.0317 with a standard error of 0.3761 and 0.2883 with a standard error of 0.1381, respectively. Likewise, the amount of intraoperative hespan (500.0 ± 249.4 cc/patient vs 365.0 ± 273.6 cc/patient, P = 0.0156) and PACU crystalloid (918.4 ± 640.0 vs 534.2 ± 408.9 cc/patient, P b 0.0001) were higher in the epidural group compared to the PNB. The incidences of urinary retention (0.2 vs 0.02, P = 0.0145) and pruritis (0.17 vs 0.03, P = 0.0442) were higher in the epidural group. There was no statistical significance between rates of nausea or vomiting (0.25 vs 0.18, P = 0.1371) or respiratory desaturation (0.16 vs 0.05, P = 0.099). Even though pulmonary emboli were diagnosed in 5 patients in the epidural and none in the PNB group, the difference did not reach statistical significance. The risk of cardiac complication was similar between the groups. No patient demonstrated any evidence of local anesthetic toxicity.
Units Transfused Per Patient
Blood Transfusions 4.0
*
3.5 3.0 2.5 2.0
*
1.5
Epidural PNB
1.0 0.5 0.0 Intraoperative
PACU
3
Post PACU Discharge
* p < 0.05 Fig. 1. A comparison of the rates of intraoperative, PACU, and post PACU discharge blood transfusions.
Postoperative management of pain and side effects is a major concern following unilateral TKA. Bilateral TKA further compounds the importance of maintaining cardiovascular stability while decreasing the incidence of systemic side effects. This translates to improved safety of the surgical procedure and allows for early physical therapy, the most influential factor for good postoperative knee rehabilitation [19,20]. Pain control can be achieved by numerous different techniques: IV PCA, general anesthesia, epidural anesthesia, and PNB. Each modality of pain control has its own set of advantages and disadvantages. PNB have shown to be efficacious for unilateral TKA; however, there is uncertainty regarding their utility in bilateral TKA. We are aware of no research comparing the efficacy of PNB to epidurals for bilateral TKA in the literature. We chose to conduct a retrospective study comparing these two treatment modalities for purposes of analyzing pilot data prior to initiating a prospective randomized study. Given that the results clearly support our hypothesis that peripheral nerve blockade is associated with dramatically fewer side effects and complications than epidural in patients undergoing bilateral knee arthroplasty, it is difficult to ethically justify a prospective analysis. Patients were controlled for age, gender, weight, BMI, ASA, and DVT prophylaxis. There is a significant relationship between the episodes of hypotension, urinary retention, and pruritis at the 0.05 level. There is no statistical significance between the two groups for incidence of respiratory desaturation; however, the odds ratio suggests that the rate is 3.1 times higher in the epidural group. The odds ratio states that patients undergoing bilateral total knee arthroplasty that receive epidural anesthesia compared to peripheral nerve blocks are 3.0 times more likely to require physician intervention for hypotension. Similarly, patients receiving an epidural are 13.4 times more likely to develop urinary retention and 5.0 times more likely to develop pruritis post-operatively. Another significant finding is the amount of blood transfusions required between the two groups in the PACU and post PACU discharge. Based on parameter estimates we expect that, even when controlling for type of DVT prophylaxis, the amount of blood transfused in the PACU to be 2.81 times higher and post PACU transfusions to be 1.33 times higher in the epidural group compared to the PNB group. Although the rate of nausea or vomiting was higher in the epidural group it did not reach statistical significance. Furthermore, the study confirms results in previously published literature, that comparable pain control can be achieved between peripheral pain blocks and epidurals. Epidural and PNB were both discontinued on post operative day 2. There was no significant difference between the groups for the level of pain postoperatively in the PACU. Likewise, the number of physician interventions to manage postoperative pain and overall narcotic consumption was similar between groups. One general concern regarding peripheral nerve block is residual nerve damage. There were 3 patients with residual nerve damage out 127 total epidurals (2.4 %). Comparatively, there was 1 patient of residual nerve damage out 60 total peripheral nerve blocks (1.7%). In this study, final assessments for nerve damage were done prior to discharge. There is no standard protocol for investigating residual nerve damage. It is the authors' beliefs that when confounded with residual nerve damage, a detailed history and physical exam can be done to determine the degree and extent of injury. Minor sensory deficits can be monitored and generally resolve with time. Extensive deficits, motor deficits, or minor sensory deficits that fail to resolve warrant investigation with a neurology consult and electromyography at 3 weeks postoperatively and repeat studies as indicated by persistence of signs and symptoms. Patients who receive epidurals with residual nerve damage resulting in severe back pain, or significant motor/sensory changes should be investigated emergently with neurosurgical consult and MRI. Our study did not result in any major residual nerve damage and shows the relative safety using the ultrasound guided approach to a peripheral nerve blockade. Also, the length of stay
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
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N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Postoperative Complications Physician Intervention: Pulmonary Issues Physician Intervention: Cardiac Issues Physician Intervention: Pain
*
Physician Intervention: Hypotension Pulmonary Embolism Deep Vein Thrombosis
PNB
Residual Nerve Damage Cardiac Complications
Epidural
Respiratory Effects (Desaturation) Nausea/Vomiting
*
Urinary Retention
*
Pruritis 0
0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45
* p < 0.05
Rate of Complications
Fig. 2. Incidence of postoperative complications between the PNB and epidural anesthesia groups.
between epidurals and PNB were comparable (3.3 ± 0.8 to 3.5 ± 2.3). The comparable length of stay is important when taking into consideration patient satisfaction, early rehabilitation, and cost of care. In addition, there was one fall in our study which occurred in our PNB group. Several limitations were identified during the course of this study. First, the retrospective design has inherent limitations due to the inability to randomize the sample and manipulate the independent variable. Second, there are unequal sample sizes between both comparison groups mainly due to changes in pain management protocol during the study period. During the beginning of the study period, all patients at our institution undergoing bilateral knee arthroplasty received epidurals. As the superiority of PNB emerged through internal investigation, it was decided to switch the protocol that resulted in all patients receiving peripheral nerve blocks. Therefore, the discrepancies in samples size between consecutive groups were due to temporal convenience. The PNB and epidural catheters were both removed on post-operative day 2; however, the exact length of time varied depending on the initial time of the surgery. Also, the majority of patients in the epidural group had their operation done by one surgeon, while there was some variation among surgeons among the peripheral nerve block group. We hoped to control this confounding variable with our sub-analysis. No data were collected regarding any variations in surgical technique or practice patterns which may have influenced postoperative pain and side effects. However, we do not expect there to be significant differences in surgical technique and postoperative care between respective surgeons performing bilateral total knee arthroplasty at our institution. Final assessments for residual nerve damage were done prior to discharge and the incidence potentially may have been higher with a longer follow up. Due to the retrospective nature of our study, the mobilization data recorded do not allow us to comment on the difference in postoperative rehabilitation between the two groups. Finally, we would have liked to have a patient satisfaction measure endpoint as part of our study. Postoperative pain and complications after total knee arthroplasty are major concerns for healthcare providers and patients. A reduction in pain and side effects allows for early ambulation and participation in physical therapy, improving postoperative rehabilitation and patient satisfaction, while decreasing length of hospital stay and risk for nosocomial infections. Despite the limitations of a retrospective study, our data suggest that the beneficial effects of PNB as part multimodal analgesia that have been demonstrated for unilateral TKA can be extended to patients undergoing bilateral TKA.
Acknowledgments The authors wish to acknowledge the data management contributions of Deborah Smith as well as the following surgeons who participated in this study: John C. Grady-Benson, M.D., Michael E. Joyce, M.D, Robert W. McAllister, M.D, Paul B. Murray, M.D, Steven F. Schutzer, M.D, and Gordon A. Zimmermann, M.D.
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Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
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Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
Contents lists available at ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for Same-Day Bilateral Total Knee Arthroplasty Nimit Patel, MD b, Olga Solovyova, MD c, Greg Matthews, MS d, Sivasenthil Arumugam, MD e, Sanjay K. Sinha, MD e, Courtland G. Lewis, MD a a
Connecticut Joint Replacement Institute, Saint Francis Hospital, Hartford, CT Drexel Orthopaedics, Philadelphia, PA c NYU Hospital for Joint Disease, New York, NY d Department of Statistics, Storrs, CT e Woodland Anesthesiology Associates, Hartford, CT b
a r t i c l e
i n f o
Article history: Received 31 August 2011 Accepted 17 September 2014 Available online xxxx Keywords: bilateral total knee same-day peripheral nerve block epidural safety
a b s t r a c t In a retrospective analysis, we evaluated the safety and efficacy of peripheral nerve blocks (PNB) compared to epidural anesthesia in 221 consecutive patients undergoing same-day bilateral total knee arthroplasty (TKA). Primary outcome measures included: hypotension requiring physician intervention, number of blood transfusions, perioperative hespan and crystalloid consumption, incidences of respiratory desaturation, pruritis, urinary retention, and nausea/vomiting. The incidences of hypotension, urinary retention, and pruritis were all higher in the epidural group, compared to PNB. Epidural patients also required more blood transfusions and greater volumes of hespan and crystalloid. PNB are safe and efficacious modality of analgesia for same day bilateral TKA and provide adequate pain relief with a significant decrease in postoperative complications compared to epidural anesthesia. © 2014 Elsevier Inc. All rights reserved.
Total knee arthroplasty (TKA) is a commonly used and successful procedure for the treatment of degenerative diseases of the knee joint [1]. The surgery, however, results in significant postoperative pain [2–4]. Good analgesia is essential for patient satisfaction and postoperative rehabilitation. There are a number of frequently used analgesic techniques that provide satisfactory pain relief but are also associated with adverse side effects. For example, opioid drugs can result in nausea, vomiting, hypotension, respiratory depression, urinary retention, sedation, pruritus, reduced gut motility, and confusion [2,4–6]. Current techniques in pain management following TKA include the use of parenteral opioids, epidural analgesia, and peripheral nerve blocks (PNB). The ongoing goal in the fields of anesthesia and surgery is to provide a combination of reliable analgesia while minimizing adverse side effects, thereby improving patient outcome and satisfaction. Epidural anesthesia has been popular over the recent decades and has claimed to provide comparable pain relief to general anesthesia with fewer systemic side effects in TKA [7,8]. Recently, in a metaanalysis, Hu et al identified 21 independent randomized clinical trials designed to evaluate the relative efficacy of regional and general The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2014.09.015. Reprint requests: Courtland G. Lewis, MD, Orthopaedic Associates of Hartford, 85 Seymour St., Hartford, CT 06102.
anesthesia in patients undergoing total hip or knee arthroplasty. They concluded that regional anesthesia reduced the duration of surgery, incidence of post-operative nausea and vomiting, and the development of thromboembolic disease (deep-vein thrombosis and pulmonary embolism) [9]. Another randomized controlled trial reported a 50% reduction in blood transfusion requirements, further substantiating the efficacy of regional anesthetic techniques compared to general anesthesia [10]. Despite these benefits of epidural anesthesia, it was not without side effects. A number of publications have shown that the technique may cause epidural hematomas, urinary retention, spinal headache, hypotension, motor weakness, and hemodynamic instability from the sympathectomy [5,6,11]. Until recently, regional anesthetic techniques have largely been epidural or spinal procedures [12]. However, PNB have been shown to reduce the side effects associated with the aforementioned treatments while providing satisfactory pain management and improved muscle control. Three different meta-analyses, comparing systemic opioids, epidural anesthesia, and continuous PNB in randomized controlled trials, have all demonstrated comparable analgesia with a significantly lower incidence of hypotension [13,14]. Several larger observational studies comparing PNB with epidural anesthesia for lower limb surgery are also consistent with the results of the meta-analyses [15–17]. Likewise, in a cohort study of 92 patients, comparing patient controlled analgesia (PCA) morphine, continuous femoral with single shot sciatic
http://dx.doi.org/10.1016/j.arth.2014.09.015 0883-5403/© 2014 Elsevier Inc. All rights reserved.
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
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N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
block, and epidural analgesia in patients undergoing TKA, the patients in the PNB group had improved pain control, decreased incidence of cardiovascular instability, and a reduction in nausea and vomiting compared with those who had epidurals or PCA [18]. As a result of good analgesia and improved muscle control, PNBs may allow for faster mobilization of the patient and shorter hospital stay, thereby possibly reducing the risk of nosocomial infection and deep vein thrombosis. Even though combined femoral-sciatic blocks are routinely used as part of multimodal post-operative pain control after unilateral TKA, epidural and spinal anesthesia are commonly used for patients undergoing bilateral TKA. There is a paucity of data regarding the use of PNB in patients undergoing bilateral TKA. We performed a retrospective analysis comparing epidural anesthesia to combined femoral-sciatic nerve block as part of a multimodal therapy program in patients undergoing bilateral, same-day total knee arthroplasty. Materials and Methods Patients The study was conducted at a high volume joint arthroplasty center after receiving approval from the Institutional Review Board (IRB# 09-07-002). We identified 221 consecutive patients who underwent elective sequential (same day) bilateral TKA from 11/1/06 to 10/31/08 from our operative registry. Prior to 2008, the majority of patients received epidurals as standard of care. At that time, the center switched over to PNB for same day bilateral TKAs. The dates for the study were chosen so as to capture a similar number of patients for each study group. Patients were excluded if they had undergone knee revision surgery or had contraindications to regional anesthesia. Specific contraindications to regional nerve blocks include: patient refusal, local infection at the injection site, allergy to local anesthetics, bleeding disorder that carried increased risk for developing hematomas, and preexisting neuropathy. Patients who received their catheter and blocks after surgery were excluded; only patients with preoperative catheter placements were included. Patients who received epidurals combined with peripheral nerve blocks for perioperative analgesia were identified and excluded. All patients receiving PNB were given a standard premedication consisting of Celebrex 200 mg BID, pregablin 50 mg, and acetaminophen which were continued for the rest of their hospital stay. In addition, Oxycontin was added to the postoperative pain therapy. These patients were also eligible to receive oxycodone or iv hydromorphone for breakthrough pain, if needed. All patients received DVT prophylaxis with Coumadin, Lovenox, or heparin postoperatively based on surgeon preference. Patients received Coumadin for 1 month with an INR goal of 1.8–2.3 due to increased concerns of bleeding. The remaining patients, minus one, received Lovenox for 10 days followed by aspirin for 6 weeks postoperatively. Heparin was used in one patient in our study due to surgeon preference. Anesthetic Technique PNB were placed with the patient supine, under strict sterile preparation and precautions. Ultrasound guided placement of continuous femoral nerve block was performed (18G Tuohy needle and stimulating catheter) with the catheter about 5 to 6 cm beyond the needle tip, and a bolus dose of 0.2% ropivacaine was administered. After securing the catheter, the patient was turned lateral with the side to be blocked superior. Again, under sterile preparation and precautions, a single dose sciatic nerve block was performed at the lower posterior thigh with 0.2% ropivacaine. The same technique was done to the contralateral side. All patients received laryngeal mask airway general anesthesia for surgery. On average, patients received 14 ± 2.0 cc and 14 ± 1.9 cc of ropivacaine for both left and right femoral nerves respectively, and 14 ± 2.1 cc and 14 ± 2.2 cc of ropivacaine for both left and
right sciatic nerve blocks respectively. All PNB were discontinued and catheters removed by 6 AM on post operative day 2. In the epidural group, blocks were placed with the patient either sitting up or lying in the lateral decubitus position, under strict sterile preparation and precautions. The L3-4 or L2-3 interspace was identified and infiltrated locally with 1% lidocaine. Upon identification of the epidural space with loss of resistance, using an 18G Tuohy needle, an epidural catheter was inserted (usually 4 to 5 cm in epidural space), secured in place, and a test dose (3 cc of 1.5% lidocaine with epinephrine) was administered. Following this, a bolus dose of 0.25% bupivacaine was administered. The patient was then taken to the operating room and received general anesthesia. Patients in the epidural group on average received a 12 ± 4.4 cc bolus of bupivacaine. All patients received laryngeal mask anesthesia and IV sedation for surgery. All epidural catheters were removed on postoperative day two. Outcome Measures Outcome measures included: (i) adverse effects: hypotension requiring physician intervention (a 25% or greater fall in systolic blood pressure), number of blood transfusions, perioperative hespan and crystalloid consumption, incidences of respiratory desaturation (any incidence of saturation below 95%), pruritis, urinary retention, and nausea and vomiting; (ii) analgesic efficacy: the number of physician interventions for postoperative pain control. We also report other secondary outcome data, including length of stay, patient falls, cardiac complications, pulmonary emboli, and residual peripheral nerve damage. As the majority of the cases were performed by one surgeon, a subanalysis of his patient cohort was conducted. Twenty-eight PNB patients were compared to 102 epidural patients. The same outcome measures were used for the subanalysis. The subanalysis data are included in the supplement to this paper. Statistical Methods All statistical analysis was conducted using SAS Software (SAS Institute Inc, Cary, NC). Several modeling strategies were employed on the basis of the type of data generated for a given side effect. For those that generated binary data (a patient either experiences the given side effect or does not) logistic regression was used. For count and continuous data, negative binomial regression was used. All models were first built using all of the available data for the overall analysis. Subsequently, just the data for the surgeon who performed the majority of the procedures were used to build the models a second time. For each side effect, a model was built controlling for gender, age, BMI, ASA score, and DVT prophylaxis (Coumadin or Lovenox). ASA score was used to create an indicator variable with a high level (ASA = 3 or 4) and a low level (ASA = 1 or 2). P-values, odds ratios, and 95% confidence intervals were calculated for the binary data. P-values and parameter estimates were calculated for the count and continuous data. Source of Funding No external funding was received for this study. Results From 11/1/06 to 10/31/08 there were 221 patients who had bilateral total knee arthroplasties performed at our institution. Of these patients, only 187 were included in the analysis; 127 of them had epidural and 60 had PNB. The remaining 34 patients were not included in the study as they had PCA or a combination of epidural with single injection femoral nerve block for postoperative management. Table 1 shows that there were no differences in patient characteristics. The average ages were 65.7 ± 10.3 and 65.9 ± 8.6 in the epidural and PNB groups, respectively. The ratio of men to women was also comparable, with 73 (57.5%)
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Discussion
Table 1 Preoperative Demographic Data and Length of Stay. Peripheral Nerve Block (n = 127)
Epidural (n = 60)
Age (years) Height (in) Weight (lbs) BMI LOS (days)
Mean
SD
Mean
SD
65.7 65.7 202.7 32.9 3.3
10.3 4.0 43.0 6.2 0.8
65.9 67.4 199.2 30.9 3.5
8.6 3.8 31.6 5.1 2.3
women and 54 (42.5%) men in the epidural group and 33 (55.0%) women and 27 (45.0%) men in the PNB group. None of the preoperative measurements were statistically significant including height (epidural = 65.7 ± 4.0, PNB = 67.4 ± 3.8), weight (epidural = 202.7 ± 43.0, PNB = 199.2 ± 31.6), and body mass index (epidural = 32.9 ± 6.2, PNB = 30.9 ± 5.1). Additionally, the ASA scores were mostly 2 and 3 for both groups; there was no statistically significant difference between the groups. Figs. 1 and 2 show the results of our primary and secondary outcome measures. There were no significant differences between the two groups for the level of pain in the PACU; on a scale of 0 to 10 (0 being no pain and 10 being the worst pain ever felt). Epidurals had a median PACU pain score of 3 and PNB had a median score of 1. The number of physician interventions required to manage postoperative pain prior to PACU discharge was similar between the groups, as was the narcotic consumption. However, the rate of hypotension which required physician intervention was higher in the epidural group (0.40 vs 0.17, P = 0.0099). Patients who had received epidurals also required a greater number of PACU blood transfusions (0.6 ± 1.0 vs 0.2 ± 0.4 units/patient, P = 0.0061) and post PACU discharge blood transfusions (2.0 ± 1.4 vs 1.3 ± 1.3 units/patient, P = 0.0037). The parameter estimate for PACU and post PACU blood transfusions was 1.0317 with a standard error of 0.3761 and 0.2883 with a standard error of 0.1381, respectively. Likewise, the amount of intraoperative hespan (500.0 ± 249.4 cc/patient vs 365.0 ± 273.6 cc/patient, P = 0.0156) and PACU crystalloid (918.4 ± 640.0 vs 534.2 ± 408.9 cc/patient, P b 0.0001) were higher in the epidural group compared to the PNB. The incidences of urinary retention (0.2 vs 0.02, P = 0.0145) and pruritis (0.17 vs 0.03, P = 0.0442) were higher in the epidural group. There was no statistical significance between rates of nausea or vomiting (0.25 vs 0.18, P = 0.1371) or respiratory desaturation (0.16 vs 0.05, P = 0.099). Even though pulmonary emboli were diagnosed in 5 patients in the epidural and none in the PNB group, the difference did not reach statistical significance. The risk of cardiac complication was similar between the groups. No patient demonstrated any evidence of local anesthetic toxicity.
Units Transfused Per Patient
Blood Transfusions 4.0
*
3.5 3.0 2.5 2.0
*
1.5
Epidural PNB
1.0 0.5 0.0 Intraoperative
PACU
3
Post PACU Discharge
* p < 0.05 Fig. 1. A comparison of the rates of intraoperative, PACU, and post PACU discharge blood transfusions.
Postoperative management of pain and side effects is a major concern following unilateral TKA. Bilateral TKA further compounds the importance of maintaining cardiovascular stability while decreasing the incidence of systemic side effects. This translates to improved safety of the surgical procedure and allows for early physical therapy, the most influential factor for good postoperative knee rehabilitation [19,20]. Pain control can be achieved by numerous different techniques: IV PCA, general anesthesia, epidural anesthesia, and PNB. Each modality of pain control has its own set of advantages and disadvantages. PNB have shown to be efficacious for unilateral TKA; however, there is uncertainty regarding their utility in bilateral TKA. We are aware of no research comparing the efficacy of PNB to epidurals for bilateral TKA in the literature. We chose to conduct a retrospective study comparing these two treatment modalities for purposes of analyzing pilot data prior to initiating a prospective randomized study. Given that the results clearly support our hypothesis that peripheral nerve blockade is associated with dramatically fewer side effects and complications than epidural in patients undergoing bilateral knee arthroplasty, it is difficult to ethically justify a prospective analysis. Patients were controlled for age, gender, weight, BMI, ASA, and DVT prophylaxis. There is a significant relationship between the episodes of hypotension, urinary retention, and pruritis at the 0.05 level. There is no statistical significance between the two groups for incidence of respiratory desaturation; however, the odds ratio suggests that the rate is 3.1 times higher in the epidural group. The odds ratio states that patients undergoing bilateral total knee arthroplasty that receive epidural anesthesia compared to peripheral nerve blocks are 3.0 times more likely to require physician intervention for hypotension. Similarly, patients receiving an epidural are 13.4 times more likely to develop urinary retention and 5.0 times more likely to develop pruritis post-operatively. Another significant finding is the amount of blood transfusions required between the two groups in the PACU and post PACU discharge. Based on parameter estimates we expect that, even when controlling for type of DVT prophylaxis, the amount of blood transfused in the PACU to be 2.81 times higher and post PACU transfusions to be 1.33 times higher in the epidural group compared to the PNB group. Although the rate of nausea or vomiting was higher in the epidural group it did not reach statistical significance. Furthermore, the study confirms results in previously published literature, that comparable pain control can be achieved between peripheral pain blocks and epidurals. Epidural and PNB were both discontinued on post operative day 2. There was no significant difference between the groups for the level of pain postoperatively in the PACU. Likewise, the number of physician interventions to manage postoperative pain and overall narcotic consumption was similar between groups. One general concern regarding peripheral nerve block is residual nerve damage. There were 3 patients with residual nerve damage out 127 total epidurals (2.4 %). Comparatively, there was 1 patient of residual nerve damage out 60 total peripheral nerve blocks (1.7%). In this study, final assessments for nerve damage were done prior to discharge. There is no standard protocol for investigating residual nerve damage. It is the authors' beliefs that when confounded with residual nerve damage, a detailed history and physical exam can be done to determine the degree and extent of injury. Minor sensory deficits can be monitored and generally resolve with time. Extensive deficits, motor deficits, or minor sensory deficits that fail to resolve warrant investigation with a neurology consult and electromyography at 3 weeks postoperatively and repeat studies as indicated by persistence of signs and symptoms. Patients who receive epidurals with residual nerve damage resulting in severe back pain, or significant motor/sensory changes should be investigated emergently with neurosurgical consult and MRI. Our study did not result in any major residual nerve damage and shows the relative safety using the ultrasound guided approach to a peripheral nerve blockade. Also, the length of stay
Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015
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N. Patel et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Postoperative Complications Physician Intervention: Pulmonary Issues Physician Intervention: Cardiac Issues Physician Intervention: Pain
*
Physician Intervention: Hypotension Pulmonary Embolism Deep Vein Thrombosis
PNB
Residual Nerve Damage Cardiac Complications
Epidural
Respiratory Effects (Desaturation) Nausea/Vomiting
*
Urinary Retention
*
Pruritis 0
0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45
* p < 0.05
Rate of Complications
Fig. 2. Incidence of postoperative complications between the PNB and epidural anesthesia groups.
between epidurals and PNB were comparable (3.3 ± 0.8 to 3.5 ± 2.3). The comparable length of stay is important when taking into consideration patient satisfaction, early rehabilitation, and cost of care. In addition, there was one fall in our study which occurred in our PNB group. Several limitations were identified during the course of this study. First, the retrospective design has inherent limitations due to the inability to randomize the sample and manipulate the independent variable. Second, there are unequal sample sizes between both comparison groups mainly due to changes in pain management protocol during the study period. During the beginning of the study period, all patients at our institution undergoing bilateral knee arthroplasty received epidurals. As the superiority of PNB emerged through internal investigation, it was decided to switch the protocol that resulted in all patients receiving peripheral nerve blocks. Therefore, the discrepancies in samples size between consecutive groups were due to temporal convenience. The PNB and epidural catheters were both removed on post-operative day 2; however, the exact length of time varied depending on the initial time of the surgery. Also, the majority of patients in the epidural group had their operation done by one surgeon, while there was some variation among surgeons among the peripheral nerve block group. We hoped to control this confounding variable with our sub-analysis. No data were collected regarding any variations in surgical technique or practice patterns which may have influenced postoperative pain and side effects. However, we do not expect there to be significant differences in surgical technique and postoperative care between respective surgeons performing bilateral total knee arthroplasty at our institution. Final assessments for residual nerve damage were done prior to discharge and the incidence potentially may have been higher with a longer follow up. Due to the retrospective nature of our study, the mobilization data recorded do not allow us to comment on the difference in postoperative rehabilitation between the two groups. Finally, we would have liked to have a patient satisfaction measure endpoint as part of our study. Postoperative pain and complications after total knee arthroplasty are major concerns for healthcare providers and patients. A reduction in pain and side effects allows for early ambulation and participation in physical therapy, improving postoperative rehabilitation and patient satisfaction, while decreasing length of hospital stay and risk for nosocomial infections. Despite the limitations of a retrospective study, our data suggest that the beneficial effects of PNB as part multimodal analgesia that have been demonstrated for unilateral TKA can be extended to patients undergoing bilateral TKA.
Acknowledgments The authors wish to acknowledge the data management contributions of Deborah Smith as well as the following surgeons who participated in this study: John C. Grady-Benson, M.D., Michael E. Joyce, M.D, Robert W. McAllister, M.D, Paul B. Murray, M.D, Steven F. Schutzer, M.D, and Gordon A. Zimmermann, M.D.
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Please cite this article as: Patel N, et al, Safety and Efficacy of Continuous Femoral Nerve Catheter with Single Shot Sciatic Nerve Block vs Epidural Catheter Anesthesia for ..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.09.015