The Journal of Arthroplasty xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty Tariq Al-Zahrani, M.D. a, Khaled S. Doais, M.D. b, Fawzi Aljassir, M.D. c, Ibrahim Alshaygy, M.D. c, Waleed Albishi, M.D. c, Abdullah S. Terkawi, M.D. b, d a
Department of Anesthesiology, King Saud University, Riyadh, Saudi Arabia Department of Anesthesiology, King Fahad Medical City, Riyadh, Saudi Arabia c Department of Orthopedic, King Saud University, Riyadh, Saudi Arabia d Department of Anesthesiology, University of Virginia, Charlottesville, VA b
a r t i c l e
i n f o
Article history: Received 11 April 2014 Accepted 28 July 2014 Available online xxxx Keywords: continuous femoral nerve block epidural analgesia total knee arthroplasty
a b s t r a c t Pain control following total knee arthroplasty (TKA) is crucial to hasten rehabilitation and decrease morbidity. We evaluated whether there is a difference between epidural infusion and continuous femoral nerve block with respect to postoperative pain control and rehabilitation course. Fifty patients completed the study. There was no statistically significant difference in the pain scores (P = 0.33), morphine consumption (P = 0.09) mean blood pressure or heart rate (P = 0.957, and P = 0.716) between groups. The postoperative daily mobilization (P = 0.80), knee joint range of motion (P = 0.83), and straight leg test (P = 0.99) were also similar between both groups. Patients were highly satisfied with their pain management in both groups without statistically significant difference (P = 0.98). © 2014 Elsevier Inc. All rights reserved.
Pain remains one of the major challenges for anesthesiologists following total knee arthroplasty (TKA). Despite the tremendous work in this field almost half of the patients still have moderate to severe pain following TKA [1]. The impact of severe pain after TKA is not only unpleasant, but may be associated with severe systemic complications [1]. Multiple pain management modalities have been evaluated: patient controlled analgesia (PCA), continuous epidural infusion (CEI), “three-in-one” block [2], single shot femoral and sciatic nerve blocks [3], continuous femoral nerve block (CFNB), continuous posterior lumbar plexus block [4], and unilateral spinal anesthesia [5]. However, optimum analgesia after TKA is still an unresolved issue. A systematic review of these studies has failed to prove superiority of any one approach over another and has failed to prove utility of adding sciatic nerve block to femoral nerve block in controlling postoperative TKA pain [6]. One of the major drawbacks of both FNB and CEI is prolonged motor blockade that prevents early mobilization thereby increasing the length of stay with persistent quadriceps weakness, and increased risk of falling [7]. It has been found that the use of ultrasound guidance helps to achieve more effective FNB with minimal local anesthetic volume The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2014.07.032. Reprint requests: Abdullah S. Terkawi, M.D., Department of Anesthesiology, University of Virginia, Charlottesville, VA.
[8,9]. However, there are few studies that compare the use of ultrasound guided CFNB with CEI, and their results were inconclusive and contradictory [10–12]. The aim of this randomized clinical trial was to compare ultrasound-guided CFNB in addition to single shot sciatic nerve block by the standard CEI in terms of postoperative pain control, hemodynamic changes, rehabilitation course and patients pain management satisfaction.
Methodology Enrollment Following institutional review board approval (King Saud University, Riyadh, Saudi Arabia, number E.12.589) patients' consent was obtained prior to enrollment. Fifty-six patients who were scheduled for unilateral knee total knee arthroplasty (TKA) were randomized (1:1) in a prospective, parallel, randomized control trial. The study conducted during the period between January 2012 and May 2013. Patients who planned for unilateral TKA and aged between 18 and 75 years regardless of their gender and BMI were considered eligible. Those with bilateral TKA or revision surgery, or has sickle cell disease, or allergy to local anesthetics were excluded. This study was designed and written according to the CONSORT 2010 statement [13].
http://dx.doi.org/10.1016/j.arth.2014.07.032 0883-5403/© 2014 Elsevier Inc. All rights reserved.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
2
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Randomization Patients were randomized into two groups: continuous epidural infusion (CEI group), and continuous femoral nerve block with single shot sciatic nerve block (CFNB group). A computerized random number generator was used. Numbers were stored in opaque sealed envelopes. The patient was asked to select one envelope on the morning of surgery. Perioperative Management and Procedures Patients were premedicated with intravenous midazolam (1 to 2 mg) in the holding area. The regional analgesia was performed in the operating theater under standard monitoring (i.e. blood pressure, heart rate, pulse oxymeter and 3-leads EKG). After skin disinfection with iodine and covering the block site with a sterile drape, intradermal 2% lidocaine was used for local anesthesia. Procedures were performed as follow: • CEI group: an epidural catheter (Portex®, Epidural Maxipack, Smiths Medical, UK) was place at the L3/4 or L4/5 level using a 17G Tuohy needle then inserted upward by 4 cm. Infused with 0.0625% bupivacaine + fentanyl (2 mcg/ml) with rate 5–10 ml/hour was started after initial bolus of 10 ml of 0.25% bupivacaine + 50 mcg fentanyl preoperatively. We selected to use 0.0625% bupivacaine concentration to fasten early mobilization as this concentration was previously used for walking epidural [14]. The catheter was covered with a sterile dressing to avoid dislodging and maintain sterility. The procedure performed in a sitting position. • Ultrasound-guided CFNB: was performed according to the method described by Koscielniak-Nielsen et al [15]. While the patient was in supine position, a femoral nerve catheter (PAJUNK®, Geisingen, Germany) was place through a Touhy 18G × 100 mm cannula, and infused at a rate of 5 ml/hour 0.2% bupivacaine after initial bolus of 10 ml 0.25% bupivacaine under ultrasound guidance. In addition, all patients in this group had a single shot sciatic nerve block with 15 ml of 0.25% bupivacaine preoperatively under ultrasound guidance through anterior approach. The catheter was placed perpendicular to the femoral nerve, as a previously described by Wang et al [16]. The catheter was sutured to the skin to avoid
dislodgment then covered with a sterile dressing. All blocks were done one by senior anesthesiologist (TZ). Blocks were performed under ultrasound guidance (M-Turbo, SonoSite Inc., Seattle, WA, USA) using a 15-MHz linear transducer. The efficacy of the epidural and nerve blocks was assessed before the induction of anesthesia, by checking the motor and sensory blocks density and distribution. General anesthesia was performed with 1 mcg/kg fentanyl and 2 mg/kg propofol, and a laryngeal airway mask (LMA) was inserted thereafter. The patients were mechanically ventilated, and Sevoflurane in air/oxygen without N2O was used for maintenance. Intraoperative boluses of fentanyl (25–50 mcg), fluid, blood pressure and blood management were administered by the attending anesthesiologists based on clinical criteria. After anesthesia emergence, all patients were started on a patient-controlled analgesia (PCA) for rescue analgesia. The PCA was programmed to give 1 mg of morphine sulfate with a lockout of 8 minutes without background infusion. Outcome Measurements (End Points) Primary Outcomes Postoperative pain scores [measuring the numerical rating score (NRS) in the scale of 0 to 10, where 0 = no pain and 10 = worst pain ever can tolerate], and postoperative morphine consumption. Each of these outcomes was recorded every 6 hours after the patient’s discharge from post-anesthesia recovery unit (PACU) for up to 72 hours. All these measurements were collected by the acute pain service specialized nurses who were unaware of the study. Secondary Outcomes (1) Postoperative hemodynamic changes, reported as mean blood pressure (MAP) and heart rate variation in the first 72 hours after discharge from PACU. (2) Postoperative rehabilitation course, which was assessed by the physiotherapy team (who were unaware of the study) once daily as follows: maximum distance that the patient can walk (in meter) during the rehabilitation section, measuring the range of the knee joint motion using a goniometer, and the straight leg raising test (where the patient was asked to rise his leg from supine position as much as he/she can) to assess the ipsilateral motor block. (3) Patient
Fig. 1. CONSORT 2010 flow chart.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx Table 1 Demographic and Clinical Characteristics of the Patients.
Characteristic Age (years) Gendera • Male • Female Body mass index (kg/m2) ASA classificationa • ASA I • ASA II Duration of surgery (minutes) Tourniquet time (minutes) Intraoperative fentanyl consumption (mcg)
Epidural group (n = 25)
CFNB (n = 25)
P-value
60 ± 8.5
62 ± 7.5
0.277
7 18 33 ± 5
8 17 33 ± 5
1 1 0.696
2 23 123 ± 15 119 ± 16 25 ± 38
6 19 123 ± 19 114 ± 24 50 ± 67
0.263 0.805 0.909 0.374 0.102
CFNB = continuous femoral nerve block. Data were presented as mean and standard deviation, and compared with simple t-test. a Presented as number and percent, and P-values were calculated by chi-square and Fisher exact test.
satisfaction with pain management (reported as 0 = I am not satisfied, 1 = I am partially satisfied, and 2 = I am completely satisfied), assessed at the time of catheter (epidural or femoral) removal.
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The Shapiro–Wilk test, histograms and Q-Q plots were used to assess the normality of each variable distribution. Mean and standard deviation were used for descriptive analysis of normally distributed variables, while median and 95% confidence interval for non-normally distributed. Two-sample t-test was used to compare parametric variables and Mann–Whitney U test for non-parametric variables. Categorical measurements are presented as numbers and percent, and compared with chi-square or Fisher exact tests as applicable. For outcomes with repeatedly measured (e.g. NRS, morphine consumption and hemodynamic changes), repeated-measures ANOVA were used to evaluate the difference with respect to time. Significance was accepted at the 5%. Statistical analysis and figures were performed using SPSS 21 software (SPSS, Chicago, IL) and R version 3.0.2 (The R Foundation for Statistical Computing, Vienna, Austria).
Results A CONSORT trial flow diagram is presented in Fig. 1. Results from fifty patients, whom underwent unilateral total knee arthroplasty (TKA), were analyzed. There was no statistically significant difference in demographic profile or in clinical characteristics (Table 1).
Primary Outcomes Statistical Analysis The sample size was calculated based on Davies et al [3] findings of median pain score of 5.5 in the epidural group and a median of 4 in the (3-in-1) block group, with a standard deviation around 2, at 24 hours post-surgery. We calculated the sample size with alpha 0.05 and beta 0.2, using a two-sample t-test. A sample size of 23 patients in each group deemed to be adequate.
There were no statistically significant difference between the epidural and CFNB groups in pain scores during the first 72 hours postoperatively (P = 0.334; ANOVA). Postoperative morphine consumption was found not to be statistically different in between the two groups (P = 0.096; ANOVA). Fig. 2 illustrates the difference between the two groups in postoperative numerical pain scores and morphine consumption.
Fig. 2. Mean and standard error. (A) The difference between the pain scores (NRS) between the two groups. (B) Morphine consumption.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
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Fig. 3. Hemodynamic profile comparison between the two groups, presented as mean and standard error. (A) Heart rate and (B) mean arterial pressure (MAP).
Secondary Outcomes There was no difference in the mean arterial pressure or the heart rate in the first 72 hours (P = 0.957, and P = 0.716; ANOVA). Fig. 3, illustrates the mean arterial pressure and heart rate for both groups in the first 72 hours which were not different. Postoperative rehabilitation course did not show a statistically significant difference in all aspects that were measured. Fig. 4A illustrates the similar distance of maximum mobilization between the epidural and CFNB patients (P = 0.808; ANOVA), while in both groups the patients' mobilization progresses daily in a significant manner (P b 0.0001). Fig. 4B, also illustrates a very similar range of knee joint motion between the two groups (P = 0.830; ANOVA), with a significant improvements over days in both groups were occurred (P b 0.0001). Table 2, summarizes different methods of rehabilitation assessment that also shows no statistical difference between the two groups. No full down cases or patients local anesthetic toxicity was reported in this cohort Thirty-two percent (n = 8) of the patients in the epidural group were partially satisfied with their pain management, while 68% (n = 17) were completely satisfied. On the other hand, 36% (n = 9) of the patients in the CFNB group were partially satisfied, with 64% (n = 16) completely satisfied. No statistical differences were detected between the two groups. Discussion The ideal analgesia for TKA should provide robust pain control, limited side effects, with minimal effect on motor power facilitating early postoperative mobilization, balance, and rehabilitation. A clear benefit of regional analgesia/anesthesia (epidural and peripheral nerve blocks) over general anesthesia and/or systemic analgesia has been demonstrated in reducing postoperative pain, morphine
consumption, and opioid-related adverse effects. Length of stay may be also reduced and rehabilitation facilitated for patients undergoing regional analgesia/anesthesia for TKA [17]. In theory, peripheral nerve block has the advantage of sparing motor control in one leg to allow for early mobilization with crutches. However, its equivalence of pain control with neuraxial analgesia is controversial. Epidural analgesia has been thought to be the “gold standard” of pain relief after total knee arthroplasty [18], and some studies have suggested that it is superior to CFNB for pain control, especially in the early postoperative hours [10,11]. While other studies showed superiority of CFNB over epidural [12]. In our study, we found that both techniques were equivalent in pain management and in facilitating rehabilitation course. Indeed, both techniques provided excellent analgesia with minimal systematic morphine consumption (Fig. 2). In fact, even with using low analgesic concentrations [5 ml/hour 0.2% bupivacaine for femoral nerve block and 0.0625% bupivacaine with fentanyl (2 mcg/ml) at rate 5–10 ml/hour] in both groups, to minimize the effect in motor power and reduce the systemic opioids side effects, the postoperative pain management was adequate and morphine consumption was minimal. Hemodynamic changes were not concerning and the rehabilitation course was excellent. Thus, from our findings we would conclude that the techniques are equivalent. The analgesic drug concentration and volume, as well as the femoral nerve block technique used (e.g. ultrasound versus nerve stimulator), seem to determine the variability in the outcomes in these cases. Barrington et al used bupivacaine 0.2% with median infusion rate 9.3 ml/hour for CFNB and ropivacaine 0.2% with fentanyl 4 mcg/ml (median infusion rate 7.6 ml/hour) for CEI, they showed equivalent pain scores, range of movement, and rehabilitation in both groups [19]. Sundarathiti et al used 0.125% levobupivacaine (8 ml/hour) for CFNB, and found that patients had significantly higher postoperative pain at 6 and 12 hours with higher tramadol consumption in
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
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24 hours. Common side-effects were more common in the CEI group [11]. Sakai et al used ropivacaine 0.15% into both CEI and CFNB, and found that patients in the CFNB group attained earlier knee flexion to 120°, less pain during rehabilitation, and less need for adjuvant analgesics [12]. The systemic side effect profile for CEI was higher in most studies. Lorenzini et al reported that 68% of patients had nausea or vomiting, 66% had urinary retention, and 58% had pruritus after 24 hours of epidural infusion [20]. However, Zaric et al found one or more side effects were present in 87% of patients in the epidural group whereas only 35% of patients in the femoral and sciatic block groups were affected on the first postoperative day [18]. On the other hand, CFNB has been found to reduce the incidence of postoperative delirium [21]. The use of ultrasound guidance to place the catheter and the concentration and amount of anesthetics used seem to affect the potency and efficacy of the CFNB. Ultrasound-guided CFNB (0.2% bupivacaine infusion at 5 ml/hour, with single shot sciatic nerve block with 15 ml of 0.25% bupivacaine) seems to have similar analgesic effects and rehabilitation course to CEI [0.0625% bupivacaine + fentanyl (2 mcg/ml) at 5–10 ml/hour]. A potential limitation for this study is the fact that preoperative mental health status was not assessed, which might play an important role in the patient's pain and the results of this study. As such, we cannot rule out a significant effect of the patient's mental health on their pain perception. In conclusion, our study found that both techniques were excellent in terms of postoperative pain score, systemic opioid consumption, and hospital rehabilitation course. The use of ultrasound-guided continuous femoral nerve block for postoperative pain control in unilateral knee arthroplasty can be a good alternative to continuous epidural analgesia.
References
Fig. 4. Median and 95% CI. (A) Daily patient mobilization at the time of the physiotherapist visit. (B) Daily assessment of knee joint range of motion (ROM).
comparison to the CEI (maintained by continuous infusion of 0.125% levobupivacaine with morphine 0.0125 mg/ml at 4 ml/hour) [10]. In another cohort, Shanthanna et al did use 0.125% bupivacaine mixed with 2 mcg/ml fentanyl for both groups, they found that pain scores were significantly higher in the femoral group at 6 hours, after which there was a declining trend, and scores were essentially similar from
Table 2 Secondary Outcomes (Rehabilitation Profile). Epidural group n = 25 Parameter
Day 1
Day 2
Day 3
CFNB group n = 25 Day 1
Day 2
Day 3
P-value
Number of patients 15 (60) 17 (68) 18 (72) 14 (56) 17 (68) 23 (92) 0.988 achieved knee joint movement (N90°) Straight leg test 12 (48) 7 (28) 5 (20) 10 (40) 7 (28) 4 (16) 0.998 • Dependent
•
Independent
13 (52) 18 (72) 20 (80) 15 (60) 18 (72) 21 (84) 0.999
CFNB = continuous femoral nerve block. Data presented as number and percent (%), and P-values were calculated by chi-square and Fisher exact test.
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Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
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15. Koscielniak-Nielsen ZJ, Rasmussen H, Hesselbjerg L. Long-axis ultrasound imaging of the nerves and advancement of perineural catheters under direct vision: a preliminary report of four cases. Reg Anesth Pain Med 2008;33(5): 477–82. 16. Wang AZ, Gu L, Zhou QH, et al. Ultrasound-guided continuous femoral nerve block for analgesia after total knee arthroplasty: catheter perpendicular to the nerve versus catheter parallel to the nerve. Reg Anesth Pain Med 2010;35(2): 127–31. 17. Macfarlane AJ, Prasad GA, Chan VW, et al. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res 2009;467(9): 2379–402.
18. Zaric D, Boysen K, Christiansen C, et al. A comparison of epidural analgesia with combined continuous femoral-sciatic nerve blocks after total knee replacement. Anesth Analg 2006;102(4):1240–6. 19. Barrington MJ, Olive D, Low K, et al. Continuous femoral nerve blockade or epidural analgesia after total knee replacement: a prospective randomized controlled trial. Anesth Analg 2005;101(6):1824–9. 20. Lorenzini C, Moreira LB, Ferreira MB. Efficacy of ropivacaine compared with ropivacaine plus sufentanil for postoperative analgesia after major knee surgery. Anaesthesia 2002;57(5):424–8. 21. Kinjo S, Lim E, Sands LP, et al. Does using a femoral nerve block for total knee replacement decrease postoperative delirium? BMC Anesthesiol 2012;12:4.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
Contents lists available at ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty Tariq Al-Zahrani, M.D. a, Khaled S. Doais, M.D. b, Fawzi Aljassir, M.D. c, Ibrahim Alshaygy, M.D. c, Waleed Albishi, M.D. c, Abdullah S. Terkawi, M.D. b, d a
Department of Anesthesiology, King Saud University, Riyadh, Saudi Arabia Department of Anesthesiology, King Fahad Medical City, Riyadh, Saudi Arabia c Department of Orthopedic, King Saud University, Riyadh, Saudi Arabia d Department of Anesthesiology, University of Virginia, Charlottesville, VA b
a r t i c l e
i n f o
Article history: Received 11 April 2014 Accepted 28 July 2014 Available online xxxx Keywords: continuous femoral nerve block epidural analgesia total knee arthroplasty
a b s t r a c t Pain control following total knee arthroplasty (TKA) is crucial to hasten rehabilitation and decrease morbidity. We evaluated whether there is a difference between epidural infusion and continuous femoral nerve block with respect to postoperative pain control and rehabilitation course. Fifty patients completed the study. There was no statistically significant difference in the pain scores (P = 0.33), morphine consumption (P = 0.09) mean blood pressure or heart rate (P = 0.957, and P = 0.716) between groups. The postoperative daily mobilization (P = 0.80), knee joint range of motion (P = 0.83), and straight leg test (P = 0.99) were also similar between both groups. Patients were highly satisfied with their pain management in both groups without statistically significant difference (P = 0.98). © 2014 Elsevier Inc. All rights reserved.
Pain remains one of the major challenges for anesthesiologists following total knee arthroplasty (TKA). Despite the tremendous work in this field almost half of the patients still have moderate to severe pain following TKA [1]. The impact of severe pain after TKA is not only unpleasant, but may be associated with severe systemic complications [1]. Multiple pain management modalities have been evaluated: patient controlled analgesia (PCA), continuous epidural infusion (CEI), “three-in-one” block [2], single shot femoral and sciatic nerve blocks [3], continuous femoral nerve block (CFNB), continuous posterior lumbar plexus block [4], and unilateral spinal anesthesia [5]. However, optimum analgesia after TKA is still an unresolved issue. A systematic review of these studies has failed to prove superiority of any one approach over another and has failed to prove utility of adding sciatic nerve block to femoral nerve block in controlling postoperative TKA pain [6]. One of the major drawbacks of both FNB and CEI is prolonged motor blockade that prevents early mobilization thereby increasing the length of stay with persistent quadriceps weakness, and increased risk of falling [7]. It has been found that the use of ultrasound guidance helps to achieve more effective FNB with minimal local anesthetic volume The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2014.07.032. Reprint requests: Abdullah S. Terkawi, M.D., Department of Anesthesiology, University of Virginia, Charlottesville, VA.
[8,9]. However, there are few studies that compare the use of ultrasound guided CFNB with CEI, and their results were inconclusive and contradictory [10–12]. The aim of this randomized clinical trial was to compare ultrasound-guided CFNB in addition to single shot sciatic nerve block by the standard CEI in terms of postoperative pain control, hemodynamic changes, rehabilitation course and patients pain management satisfaction.
Methodology Enrollment Following institutional review board approval (King Saud University, Riyadh, Saudi Arabia, number E.12.589) patients' consent was obtained prior to enrollment. Fifty-six patients who were scheduled for unilateral knee total knee arthroplasty (TKA) were randomized (1:1) in a prospective, parallel, randomized control trial. The study conducted during the period between January 2012 and May 2013. Patients who planned for unilateral TKA and aged between 18 and 75 years regardless of their gender and BMI were considered eligible. Those with bilateral TKA or revision surgery, or has sickle cell disease, or allergy to local anesthetics were excluded. This study was designed and written according to the CONSORT 2010 statement [13].
http://dx.doi.org/10.1016/j.arth.2014.07.032 0883-5403/© 2014 Elsevier Inc. All rights reserved.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
2
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
Randomization Patients were randomized into two groups: continuous epidural infusion (CEI group), and continuous femoral nerve block with single shot sciatic nerve block (CFNB group). A computerized random number generator was used. Numbers were stored in opaque sealed envelopes. The patient was asked to select one envelope on the morning of surgery. Perioperative Management and Procedures Patients were premedicated with intravenous midazolam (1 to 2 mg) in the holding area. The regional analgesia was performed in the operating theater under standard monitoring (i.e. blood pressure, heart rate, pulse oxymeter and 3-leads EKG). After skin disinfection with iodine and covering the block site with a sterile drape, intradermal 2% lidocaine was used for local anesthesia. Procedures were performed as follow: • CEI group: an epidural catheter (Portex®, Epidural Maxipack, Smiths Medical, UK) was place at the L3/4 or L4/5 level using a 17G Tuohy needle then inserted upward by 4 cm. Infused with 0.0625% bupivacaine + fentanyl (2 mcg/ml) with rate 5–10 ml/hour was started after initial bolus of 10 ml of 0.25% bupivacaine + 50 mcg fentanyl preoperatively. We selected to use 0.0625% bupivacaine concentration to fasten early mobilization as this concentration was previously used for walking epidural [14]. The catheter was covered with a sterile dressing to avoid dislodging and maintain sterility. The procedure performed in a sitting position. • Ultrasound-guided CFNB: was performed according to the method described by Koscielniak-Nielsen et al [15]. While the patient was in supine position, a femoral nerve catheter (PAJUNK®, Geisingen, Germany) was place through a Touhy 18G × 100 mm cannula, and infused at a rate of 5 ml/hour 0.2% bupivacaine after initial bolus of 10 ml 0.25% bupivacaine under ultrasound guidance. In addition, all patients in this group had a single shot sciatic nerve block with 15 ml of 0.25% bupivacaine preoperatively under ultrasound guidance through anterior approach. The catheter was placed perpendicular to the femoral nerve, as a previously described by Wang et al [16]. The catheter was sutured to the skin to avoid
dislodgment then covered with a sterile dressing. All blocks were done one by senior anesthesiologist (TZ). Blocks were performed under ultrasound guidance (M-Turbo, SonoSite Inc., Seattle, WA, USA) using a 15-MHz linear transducer. The efficacy of the epidural and nerve blocks was assessed before the induction of anesthesia, by checking the motor and sensory blocks density and distribution. General anesthesia was performed with 1 mcg/kg fentanyl and 2 mg/kg propofol, and a laryngeal airway mask (LMA) was inserted thereafter. The patients were mechanically ventilated, and Sevoflurane in air/oxygen without N2O was used for maintenance. Intraoperative boluses of fentanyl (25–50 mcg), fluid, blood pressure and blood management were administered by the attending anesthesiologists based on clinical criteria. After anesthesia emergence, all patients were started on a patient-controlled analgesia (PCA) for rescue analgesia. The PCA was programmed to give 1 mg of morphine sulfate with a lockout of 8 minutes without background infusion. Outcome Measurements (End Points) Primary Outcomes Postoperative pain scores [measuring the numerical rating score (NRS) in the scale of 0 to 10, where 0 = no pain and 10 = worst pain ever can tolerate], and postoperative morphine consumption. Each of these outcomes was recorded every 6 hours after the patient’s discharge from post-anesthesia recovery unit (PACU) for up to 72 hours. All these measurements were collected by the acute pain service specialized nurses who were unaware of the study. Secondary Outcomes (1) Postoperative hemodynamic changes, reported as mean blood pressure (MAP) and heart rate variation in the first 72 hours after discharge from PACU. (2) Postoperative rehabilitation course, which was assessed by the physiotherapy team (who were unaware of the study) once daily as follows: maximum distance that the patient can walk (in meter) during the rehabilitation section, measuring the range of the knee joint motion using a goniometer, and the straight leg raising test (where the patient was asked to rise his leg from supine position as much as he/she can) to assess the ipsilateral motor block. (3) Patient
Fig. 1. CONSORT 2010 flow chart.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx Table 1 Demographic and Clinical Characteristics of the Patients.
Characteristic Age (years) Gendera • Male • Female Body mass index (kg/m2) ASA classificationa • ASA I • ASA II Duration of surgery (minutes) Tourniquet time (minutes) Intraoperative fentanyl consumption (mcg)
Epidural group (n = 25)
CFNB (n = 25)
P-value
60 ± 8.5
62 ± 7.5
0.277
7 18 33 ± 5
8 17 33 ± 5
1 1 0.696
2 23 123 ± 15 119 ± 16 25 ± 38
6 19 123 ± 19 114 ± 24 50 ± 67
0.263 0.805 0.909 0.374 0.102
CFNB = continuous femoral nerve block. Data were presented as mean and standard deviation, and compared with simple t-test. a Presented as number and percent, and P-values were calculated by chi-square and Fisher exact test.
satisfaction with pain management (reported as 0 = I am not satisfied, 1 = I am partially satisfied, and 2 = I am completely satisfied), assessed at the time of catheter (epidural or femoral) removal.
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The Shapiro–Wilk test, histograms and Q-Q plots were used to assess the normality of each variable distribution. Mean and standard deviation were used for descriptive analysis of normally distributed variables, while median and 95% confidence interval for non-normally distributed. Two-sample t-test was used to compare parametric variables and Mann–Whitney U test for non-parametric variables. Categorical measurements are presented as numbers and percent, and compared with chi-square or Fisher exact tests as applicable. For outcomes with repeatedly measured (e.g. NRS, morphine consumption and hemodynamic changes), repeated-measures ANOVA were used to evaluate the difference with respect to time. Significance was accepted at the 5%. Statistical analysis and figures were performed using SPSS 21 software (SPSS, Chicago, IL) and R version 3.0.2 (The R Foundation for Statistical Computing, Vienna, Austria).
Results A CONSORT trial flow diagram is presented in Fig. 1. Results from fifty patients, whom underwent unilateral total knee arthroplasty (TKA), were analyzed. There was no statistically significant difference in demographic profile or in clinical characteristics (Table 1).
Primary Outcomes Statistical Analysis The sample size was calculated based on Davies et al [3] findings of median pain score of 5.5 in the epidural group and a median of 4 in the (3-in-1) block group, with a standard deviation around 2, at 24 hours post-surgery. We calculated the sample size with alpha 0.05 and beta 0.2, using a two-sample t-test. A sample size of 23 patients in each group deemed to be adequate.
There were no statistically significant difference between the epidural and CFNB groups in pain scores during the first 72 hours postoperatively (P = 0.334; ANOVA). Postoperative morphine consumption was found not to be statistically different in between the two groups (P = 0.096; ANOVA). Fig. 2 illustrates the difference between the two groups in postoperative numerical pain scores and morphine consumption.
Fig. 2. Mean and standard error. (A) The difference between the pain scores (NRS) between the two groups. (B) Morphine consumption.
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
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Fig. 3. Hemodynamic profile comparison between the two groups, presented as mean and standard error. (A) Heart rate and (B) mean arterial pressure (MAP).
Secondary Outcomes There was no difference in the mean arterial pressure or the heart rate in the first 72 hours (P = 0.957, and P = 0.716; ANOVA). Fig. 3, illustrates the mean arterial pressure and heart rate for both groups in the first 72 hours which were not different. Postoperative rehabilitation course did not show a statistically significant difference in all aspects that were measured. Fig. 4A illustrates the similar distance of maximum mobilization between the epidural and CFNB patients (P = 0.808; ANOVA), while in both groups the patients' mobilization progresses daily in a significant manner (P b 0.0001). Fig. 4B, also illustrates a very similar range of knee joint motion between the two groups (P = 0.830; ANOVA), with a significant improvements over days in both groups were occurred (P b 0.0001). Table 2, summarizes different methods of rehabilitation assessment that also shows no statistical difference between the two groups. No full down cases or patients local anesthetic toxicity was reported in this cohort Thirty-two percent (n = 8) of the patients in the epidural group were partially satisfied with their pain management, while 68% (n = 17) were completely satisfied. On the other hand, 36% (n = 9) of the patients in the CFNB group were partially satisfied, with 64% (n = 16) completely satisfied. No statistical differences were detected between the two groups. Discussion The ideal analgesia for TKA should provide robust pain control, limited side effects, with minimal effect on motor power facilitating early postoperative mobilization, balance, and rehabilitation. A clear benefit of regional analgesia/anesthesia (epidural and peripheral nerve blocks) over general anesthesia and/or systemic analgesia has been demonstrated in reducing postoperative pain, morphine
consumption, and opioid-related adverse effects. Length of stay may be also reduced and rehabilitation facilitated for patients undergoing regional analgesia/anesthesia for TKA [17]. In theory, peripheral nerve block has the advantage of sparing motor control in one leg to allow for early mobilization with crutches. However, its equivalence of pain control with neuraxial analgesia is controversial. Epidural analgesia has been thought to be the “gold standard” of pain relief after total knee arthroplasty [18], and some studies have suggested that it is superior to CFNB for pain control, especially in the early postoperative hours [10,11]. While other studies showed superiority of CFNB over epidural [12]. In our study, we found that both techniques were equivalent in pain management and in facilitating rehabilitation course. Indeed, both techniques provided excellent analgesia with minimal systematic morphine consumption (Fig. 2). In fact, even with using low analgesic concentrations [5 ml/hour 0.2% bupivacaine for femoral nerve block and 0.0625% bupivacaine with fentanyl (2 mcg/ml) at rate 5–10 ml/hour] in both groups, to minimize the effect in motor power and reduce the systemic opioids side effects, the postoperative pain management was adequate and morphine consumption was minimal. Hemodynamic changes were not concerning and the rehabilitation course was excellent. Thus, from our findings we would conclude that the techniques are equivalent. The analgesic drug concentration and volume, as well as the femoral nerve block technique used (e.g. ultrasound versus nerve stimulator), seem to determine the variability in the outcomes in these cases. Barrington et al used bupivacaine 0.2% with median infusion rate 9.3 ml/hour for CFNB and ropivacaine 0.2% with fentanyl 4 mcg/ml (median infusion rate 7.6 ml/hour) for CEI, they showed equivalent pain scores, range of movement, and rehabilitation in both groups [19]. Sundarathiti et al used 0.125% levobupivacaine (8 ml/hour) for CFNB, and found that patients had significantly higher postoperative pain at 6 and 12 hours with higher tramadol consumption in
Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
T. Al-Zahrani et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx
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24 hours. Common side-effects were more common in the CEI group [11]. Sakai et al used ropivacaine 0.15% into both CEI and CFNB, and found that patients in the CFNB group attained earlier knee flexion to 120°, less pain during rehabilitation, and less need for adjuvant analgesics [12]. The systemic side effect profile for CEI was higher in most studies. Lorenzini et al reported that 68% of patients had nausea or vomiting, 66% had urinary retention, and 58% had pruritus after 24 hours of epidural infusion [20]. However, Zaric et al found one or more side effects were present in 87% of patients in the epidural group whereas only 35% of patients in the femoral and sciatic block groups were affected on the first postoperative day [18]. On the other hand, CFNB has been found to reduce the incidence of postoperative delirium [21]. The use of ultrasound guidance to place the catheter and the concentration and amount of anesthetics used seem to affect the potency and efficacy of the CFNB. Ultrasound-guided CFNB (0.2% bupivacaine infusion at 5 ml/hour, with single shot sciatic nerve block with 15 ml of 0.25% bupivacaine) seems to have similar analgesic effects and rehabilitation course to CEI [0.0625% bupivacaine + fentanyl (2 mcg/ml) at 5–10 ml/hour]. A potential limitation for this study is the fact that preoperative mental health status was not assessed, which might play an important role in the patient's pain and the results of this study. As such, we cannot rule out a significant effect of the patient's mental health on their pain perception. In conclusion, our study found that both techniques were excellent in terms of postoperative pain score, systemic opioid consumption, and hospital rehabilitation course. The use of ultrasound-guided continuous femoral nerve block for postoperative pain control in unilateral knee arthroplasty can be a good alternative to continuous epidural analgesia.
References
Fig. 4. Median and 95% CI. (A) Daily patient mobilization at the time of the physiotherapist visit. (B) Daily assessment of knee joint range of motion (ROM).
comparison to the CEI (maintained by continuous infusion of 0.125% levobupivacaine with morphine 0.0125 mg/ml at 4 ml/hour) [10]. In another cohort, Shanthanna et al did use 0.125% bupivacaine mixed with 2 mcg/ml fentanyl for both groups, they found that pain scores were significantly higher in the femoral group at 6 hours, after which there was a declining trend, and scores were essentially similar from
Table 2 Secondary Outcomes (Rehabilitation Profile). Epidural group n = 25 Parameter
Day 1
Day 2
Day 3
CFNB group n = 25 Day 1
Day 2
Day 3
P-value
Number of patients 15 (60) 17 (68) 18 (72) 14 (56) 17 (68) 23 (92) 0.988 achieved knee joint movement (N90°) Straight leg test 12 (48) 7 (28) 5 (20) 10 (40) 7 (28) 4 (16) 0.998 • Dependent
•
Independent
13 (52) 18 (72) 20 (80) 15 (60) 18 (72) 21 (84) 0.999
CFNB = continuous femoral nerve block. Data presented as number and percent (%), and P-values were calculated by chi-square and Fisher exact test.
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Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial of Continuous Femoral Nerve Block Combined with Sciatic Nerve Block Versus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032
