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Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial Kelechi R. Okoroha, M.D., Robert A. Keller, M.D., Nathan E. Marshall, M.D., Edward K. Jung, M.D., Nima Mehran, M.D., Eric Owashi, M.D., and Vasilios Moutzouros, M.D.
Purpose: To compare femoral nerve block (FNB) versus local liposomal bupivacaine (LB) for pain control in patients undergoing anterior cruciate ligament (ACL) reconstruction. Methods: Eighty-five patients undergoing primary ACL reconstruction were assessed for participation. We performed a prospective randomized trial in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement. The study arms included either intraoperative local infiltration of LB (20 mL of bupivacaine/10 mL of saline solution) or preoperative FNB with a primary outcome of postoperative pain levels (visual analog scale) for 4 days. Secondary outcomes assessed included opioid consumption (intravenous morphine equivalents), hours slept, patient satisfaction, and calls to the physician. Randomization was by a computerized algorithm. The observer was blinded and the patient was not blinded to the intervention. Results: One patient declined participation; 2 patients were excluded after randomization. A total of 82 patients were analyzed. Outcomes showed a significant increase in pain in the LB group between 5 and 8 hours postoperatively (mean standard deviation, 6.3 2.0 versus 4.8 2.6; P ¼ .01). There were no significant differences between the groups in mean daily pain levels, morphine equivalents, or patient satisfaction when we controlled for graft type, age, body mass index, and sex. Patients receiving an FNB had a nonsignificant increase in number of sleep disturbances on the day of surgery (mean standard deviation, 4.4 3.7 v 3.1 2.1; P ¼ .09) and were more likely to call their doctor the following day because of pain (29% v 8%, P ¼ .04). Six patients in the FNB group had either prolonged quadriceps inhibition or sensory disturbance. One patient in the LB group required reoperation for a flexion contracture. Conclusions: An increase in acute postoperative pain was found with LB compared with FNB for posteACL reconstruction pain control. After the acute postoperative period, there were no significant differences in opioid consumption or pain control. The occurrence of nerve irritation postoperatively was found to be higher in the FNB group. Level of Evidence: Level I, prospective randomized trial.
P
erioperative pain control after anterior cruciate ligament (ACL) reconstruction is a significant issue that can affect patient satisfaction and outcomes.1,2 Over the past 2 decades, the use of femoral nerve blocks (FNBs) has provided added pain control in ACL
From the Department of Orthopaedic Surgery, Henry Ford Hospital (K.R.O., R.A.K., N.E.M., E.K.J., N.M., E.O., V.M.); and School of Medicine, Wayne State University (E.O.), Detroit, Michigan, U.S.A. The authors report that they have no conflicts of interest in the authorship and publication of this article. Received February 1, 2016; accepted May 23, 2016. Address correspondence to Kelechi R. Okoroha, M.D., Department of Orthopaedic Surgery, Henry Ford Hospital, 2799 W Grand Blvd (CFP-6), Detroit, MI 48202, U.S.A. E-mail: [email protected] Ó 2016 by the Arthroscopy Association of North America 0749-8063/16101/$36.00 http://dx.doi.org/10.1016/j.arthro.2016.05.033
reconstructions, which are now predominantly performed as outpatient procedures.3-6 An FNB, however, is not without side effects. Complications include nerve injury, partial motor block leading to delayed quadriceps activation, residual quadriceps weakness, and inadequate nerve block coverage of the donor site in hamstring autograft ACL reconstructions.7-10 Recently, orthopaedic procedures have used local infiltration anesthesia (LIA) as an alternative mode of pain control without the need for a regional block. Recent studies on patients undergoing ACL reconstruction and total knee arthroplasty have shown LIA, using a short-acting agent or multidrug cocktail, is an effective or better alternative to FNB in managing pain while allowing increased mobilization.3,11-17 Although LIA with short-acting anesthetics has shown possible benefit, the agents used in the multimodal drug cocktail
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Table 1. Demographic Data Randomization Group Patients, n Mean age, yr Sex Female Male BMI (SD) Concomitant procedures, n Meniscectomy Meniscal repair Chondroplasty Combination Total
Graft Type
FNB 41 27.0 (range, 16-53)
LB 41 27.6 (range, 16-53)
P Value .99 .74
17 24 26.0 (6.0)
16 25 26.5 (4.6)
.94 .58
4 7 0 4 15
12 1 1 6 20
.37
BTB 47 19.7 (range, 16-31)
HS 23 33.4 (range, 18-53)
PTA 12 45.9 (range, 37-53)
20 27 25.2 (4.9)
7 16 26.9 (4.3)
7 5 29.3 (7.6)
P Value .13 .001*
.13 .03*
BMI, body mass index; BTB, bone-tendon-bone; FNB, femoral nerve block; HS, hamstring; LB, liposomal bupivacaine; PTA, posterior tibialis allograft; SD, standard deviation. *Statistically significant.
have finite half-lives, after which patients can have increased pain.3,18,19 Liposomal bupivacaine (LB), a non-opioid local anesthetic (Exparel; Pacira Pharmaceuticals, Parsippany, NJ), was created to provide a longer-acting local infiltration anesthetic. LB combines bupivacaine within a multivesicular lipid-based delivery platform (DepoFoam; Pacira Pharmaceuticals) that allows the release of the anesthetic agent over an extended period.20 LB has seen increased use in orthopaedic procedures with randomized trials suggesting increased pain relief when compared with FNB in total knee arthroplasty.17,21 The purpose of our study was to compare FNB versus local LB for pain control in patients undergoing ACL reconstruction. Our hypothesis was that in patients undergoing ACL reconstruction, treatment with LB would lead to no significant difference in mean daily pain control.
Methods The CONSORT (Consolidated Standards of Reporting Trials) statement22 was followed to conduct this singlesurgeon, prospective, observer-blinded, randomized controlled trial. The study was reviewed and approved by our institutional review board (Henry Ford Hospital Investigation Review Board) and was registered at ClinicalTrials.gov (NCT02606448). From August 2014eApril 2015, 85 consecutive patients surgically treated by the senior author (V.M.) for ACL tears were assessed for study eligibility. Eighty-four patients were consented for participation. The inclusion criteria were patients aged older than 16 years and patients undergoing primary ACL reconstruction. The exclusion criteria were documented alcohol or drug abuse, revision ACL tear,
concurrent ligamentous injuries requiring repair, and allergies or intolerance to bupivacaine. All concomitant meniscal and cartilage procedures were recorded (Table 1). The data of patients who consented to be included in the study were compiled on a secure computer database. Patients were then randomized to receive either LIA or 1-shot FNB by adaptive randomization computer software (MD Anderson Cancer Center, Houston, TX). One week before surgical intervention, the surgeon (V.M.) and anesthesiologist were notified by secure email of the patient’s group designation for the upcoming week by the project coordinator. The study did not require physician blinding because patient outcomes were self-recorded. Patients then underwent an arthroscopically assisted ACL reconstruction with bonetendon-bone autograft, hamstring autograft, or posterior tibialis allograft through anatomic femoral and tibial tunnels. Each patient individually determined his or her choice of graft type after an informed discussion on potential options with his or her surgeon. The senior author (V.M.) treated all patients to increase the consistency of each procedure and injection technique. FNB Group In the FNB group, on the day of surgery, 1 hour before surgical intervention, patients received a preoperative ultrasound-guided single-shot FNB using 40 mL of 0.5% ropivacaine with an 80-mm, 22-gauge needle. This was combined with the use of a nerve stimulator to increase the accuracy of the block. Experienced senior anesthesiologists applied all FNBs in this study. LB Group For patients in the LB group, 20 mL of LB (266 mg) was mixed with 10 mL of saline solution to increase the
LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
volume to 30 mL total. This mixture was infiltrated locally using a standardized protocol after the graft had been secured and before closure of the wound. No mixture was injected intra-articularly. The injection protocol was as follows: A 60-mL syringe with a 1-inch, 18-gauge needle was used to administer the injection. Infiltration of 20 mL was performed in 5-mL increments evenly into the graft site. In the bone-tendon-bone group, injection was performed at the bone harvest sites at the patella and tibia, as well as the periosteum. In the hamstring graft group, infiltration was performed in the soft tissues around the donor site, as well as proximally at the muscle transection site, with the use of a Foley catheter led along the tendon stripper to reach the proximal muscle. In the posterior tibialis graft group, the injection was distributed evenly between soft-tissue dissection sites. In each group neither the bone tunnels nor the graft itself was infiltrated with LB, to decrease the chances of intra-articular infiltration. The remaining 10 mL was infiltrated into the portal and incision sites evenly. Data Collection After surgery, patients were taken to the postoperative care unit, where initial opioid consumption and visual analog scale (VAS) pain scores were recorded every hour by nursing staff. Medications were standardized so that patients received 0.5 mg of hydromorphone hydrochloride every 10 minutes as needed for pain, with a maximum of 5 doses. Patients were then discharged home the day of surgery with a prescription for 60 tablets of 5 mg of hydrocodonee325 mg of acetaminophen and instructed to take 1 to 2 tablets every 4 to 6 hours as needed for pain. Because LB has a potential effectiveness of 72 hours, patients were given a pain diary binder to fill out for 4 days postoperatively, starting with the day of surgery. The pain diary allowed patients to maintain a record of their pain and opioid consumption every 4 hours. The diary also asked the patients about any side effects from the medication, as well as if they were awoken from sleep because of pain overnight and, if so, how many times. Finally, patients were asked if they had to contact their doctor’s office because of pain and if they were satisfied with their pain management. After retrieval of patients’ pain diaries, a blinded observer (E.O.) recorded outcome measures. Before statistical analysis, opioid consumption between the control and study groups was converted to intravenous morphine equivalents. This was done to convert the different opioid medications used to one factor that could be cumulated and compared directly between the groups. VAS (10-cm scale) measurements were converted to a 0- to 10-point pain rating scale.
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Statistical Analysis The primary endpoint of this study was a mean daily pain difference on a VAS of 13 mm between the FNB and LB groups. This was based on previous data showing that a difference of 13 mm on a VAS represents, on average, the minimum change in acute pain that is clinically significant.23 A power analysis was performed before the study to assess the primary hypothesis that a significant difference in mean daily pain of 13 mm on the VAS will not be found between the FNB and LB groups. With a power of 80% (b level ¼ .80, a level ¼ .05), a sample size of 25 patients per group was obtained. A sample size of 85 patients (42 per group) was selected to allow for incomplete data collection. Secondary outcomes assessed included mean intravenous morphine equivalents used, number of sleep disturbances, satisfaction with pain management, and calls to the physician because of pain. All data were collected and analyzed using R 3.2.1 software (R Core Team, 2012 [R Foundation for Statistical Computing, Vienna, Austria]). Statistical comparisons between the 2 groups regarding demographic variables, day-of-surgery raw VAS scores, and hours of sleep on each postoperative day (POD) were calculated with a 2-tailed Student t test using the mean and standard deviation of each measurement when appropriate. A preliminary test to confirm the quality of variances was conducted before using the t test to confirm the appropriate statistical analysis. We then performed a longitudinal analysis to analyze VAS scores and intravenous morphine equivalents, looking specifically at the interaction between time and the randomization group, while controlling for important covariates. To model these effects, we used multivariate generalized estimating equation models, modeling the unique effects of time, randomization group, and the interactions, while controlling for graft type, age, body mass index, and sex. A c2 test was used to compare pain satisfaction and a Fisher exact test was used to compare calls to the physician, concomitant procedures, and complications between the groups. In all analyses, P < .05 was considered statistically significant.
Results Group Demographic Characteristics Eighty-five consecutive patients surgically treated for the primary diagnosis of an ACL tear were assessed for participation in the study. One patient declined to participate and was not included. Eighty-four patients were subsequently randomized into 2 groups. Two patients who had magnetic resonance imaging evidence of an ACL tear did not undergo ACL reconstruction because of an incomplete ACL tear discovered by arthroscopy and were excluded after randomization.
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Enrollment
Assessed for eligibility (n= 85)
Not included (n= 1) Not meeting inclusion criteria (n= 0) Declined to participate (n= 1) Other reasons (n= 0)
Randomized (n= 84)
AllocaƟon Allocated to femoral nerve block (n=42) Received allocated intervention (n=41) Did not receive allocated intervention (Incomplete ACL tear on arthroscopy) (n=1)
Allocated to local liposomal bupivacaine (n=42) Received allocated intervention (n=41 ) Did not receive allocated intervention (Incomplete ACL tear on arthroscopy) (n=1)
Follow -Up Lost to follow-up (n=0) Discontinued intervention (n=0)
Lost to follow-up (n=0) Discontinued intervention (n=0)
Analysis Analyzed (n= 41) Excluded from analysis (n= 1)
Analyzed (n= 41) Excluded from analysis (n= 1)
Fig 1. CONSORT (Consolidated Standards of Reporting Trials) 2010 flow diagram. (ACL, anterior cruciate ligament.)
Data from the remaining 82 patients were included for further analysis (Fig 1). Baseline characteristics and concomitant procedures between the 2 groups are listed in Table 1. There were no statistical differences in any demographic characteristics between the 2 groups.
and 3 (P ¼ .99 and P ¼ .98, respectively) (Fig 6). Satisfaction with pain management was similar between the FNB and LB groups (Fig 7).
LB Versus FNB There was a significant increase in acute pain in the LB group between 5 and 8 hours postoperatively (mean standard deviation, 6.3 2.6 v 4.8 2.0; P ¼ .01) (Fig 2). However, when adjusted for covariates using generalized estimating equation models, there were no significant differences between mean pain levels and intravenous morphine equivalents between the LB and FNB groups on each POD (Figs 3 and 4). On evaluation of sleep patterns, we noted a nonsignificant increase in the number of sleep disturbances on POD 0 in patients receiving FNB compared with LB (mean standard deviation, 4.4 3.7 v 3.1 2.1; P ¼ .09). However, sleep disturbances were not significantly different between groups on POD 1, 2, and 3 (P ¼ .46, P ¼ .17, and P ¼ .29, respectively) (Fig 5). Patients in the FNB group were significantly more likely to call their doctor on POD 1 because of pain (28.6% v 7.5%, P ¼ .04). This value did not reach significance on POD 2
Mean Hourly Pain Levels Raw Data 8 7
p = .01
p = .06
p = .51
p = .38
p = .13
p = .06
Mean Pain Level VAS score
6 5 4
FNB
3
LB
2 1 0 0-4
5-8* 9-12 13 17-20 Time Following Surgery (in hours)
21-24
Fig 2. Raw mean hourly pain data, comparing pain levels between the 2 groups at 4-hour increments on the day of surgery. Patients in the liposomal bupivacaine (LB) group had a statistically significant increase in pain from 5-8 hours postoperatively (asterisk). (FNB, femoral nerve block; VAS, visual analog scale.)
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LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
Sleep quality Number of sleep disturbances
5 4.5 4 3
p = .17
2.5
p = .29
2 1.5 1 0.5 0
In our evaluation of postoperative complications, 2 patients in the FNB group had prolonged quadriceps inhibition. One patient had return of quadriceps function at 10 weeks and the other had resolution at 4 months with residual pain. Four patients in the FNB group had prolonged sensory disturbance in the anterior proximal thigh, which persisted in all cases at an average follow-up of 6 months. One patient in the LB group had a flexion contracture that required arthroscopic debridement of a cyclops lesion. The difference in postoperative complications between the 2 groups was
p = .46
3.5
FNB LB
Fig 3. Predicted average pain levels, averaged across patients, stratified by time interval and randomization group, while controlling for graft type, age, body mass index, and sex. There were no significant differences between the groups in predicted average pain levels when controlling for covariates. (FNB, femoral nerve block; LB, liposomal bupivacaine; VAS, visual analog scale.)
p = .09
Day 0 4.4 3.1
Day 1 3.0 2.6
Day 2 2.2 1.6
Day 3 1.6 1.2
Fig 5. Comparison of number of sleep disruptions caused by pain in patients treated with femoral nerve block (FNB) versus liposomal bupivacaine (LB) by postoperative day. No significant differences were found; however, there was a trend toward increased number of sleep disturbances on the day of surgery in the FNB group.
not statistically significant (P ¼ .06). No intraoperative complications occurred in either group.
Discussion In our evaluation of the use of LIA with LB for pain control after ACL reconstruction, the results suggest that patients treated with LB have increased pain levels in the initial postoperative hours when compared with FNB. However, after the acute postoperative period, LB provides similar pain control after ACL reconstruction when compared with FNB without the inherent risks associated with nerve blockade procedures. We also found that LB improved early sleep quality and the
35.0% 30.0%
Percentage of patients contacting the surgeon p = .04
25.0% 20.0% 15.0% p = .99
p = .98
10.0% 5.0% 0.0%
Fig 4. Predicted total medication taken, averaged across patients, stratified by time interval and randomization group, while controlling for graft type, age, body mass index, and sex. There were no significant differences between the groups in predicted total medication taken when controlling for covariates. (FNB, femoral nerve block; LB, liposomal bupivacaine.)
FNB LB
Day 1* 28.6% 7.5%
Day 2 2.9% 2.5%
Day 3 6.5% 3.1%
Fig 6. Comparison of percentage of patients who contacted their physician because of pain by day after anterior cruciate ligament reconstruction. Patients in the femoral nerve block (FNB) group were more likely to call their physician the day after surgery because of pain. An asterisk indicates a significant difference. (LB, liposomal bupivacaine.)
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Patient Satisfaction
100.0% 90.0% Mean Percent Satisfied
80.0% 70.0%
p = .19
p = .99
Day 2 68.8% 84.6%
Day 3 87.5% 90.3%
p = .62 p = .81
60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% FNB LB
Day 0 51.4% 57.1%
Day 1 54.6% 63.2%
Fig 7. Comparison of patient satisfaction with pain control by day after anterior cruciate ligament reconstruction. There was no significant difference in patient satisfaction between the 2 groups. (FNB, femoral nerve block; LB, liposomal bupivacaine.)
number of calls to the physician related to rebound pain. LIA versus FNB for pain control after ACL reconstruction has previously been evaluated, with the use of short-acting pain medications for LIA.14,15 Kristensen et al.15 evaluated 60 patients for 48 hours after randomization to FNB versus LIA with ropivacaine. They found no significant differences between the groups in pain intensity or total opioid consumption. Beyond differences in multiple surgical techniques, this study was limited in the length and frequency of pain control evaluated, as well as lack of evaluation of the effect of the pain control regimen on sleep and patient satisfaction. Our study found similar results with the use of LB for pain control with expanded evaluation of temporal pain control, adding to evidence of the usefulness of long-acting LIA for pain control after orthopaedic procedures. Although LB showed no significant differences compared with FNB regarding mean daily pain relief, there was an initial 12-hour period in which patients in the LB group had increased pain when compared with the FNB group according to raw data. This was thought to be caused by the reported 10-hour lag time before optimal local concentration of LB, resulting from the delayed release from lipid storage delivery.24 Previous studies have not determined how long it takes for patients to begin to have comparable pain relief after injection of LB. Surdam et al.21 presented evidence that patients treated with LB when undergoing unilateral total knee arthroplasty have increased pain the day of surgery when compared with FNB; however, their study did not determine specifically when, during the day of the operation, patients had increased pain. Our study suggests that there may be an increase in pain in patients treated with LB compared with FNB in the first
12 hours after surgery. After this period, pain levels begin to balance out and are not significantly different. This finding suggests that patients undergoing LIA with LB could potentially benefit from supplemental analgesics to cover the acute period postoperatively. The deleterious effects of FNB have been implicated in various studies.10,25-29 Krych et al.25 evaluated the effect of FNB on quadriceps strength and function after ACL reconstruction. Their results showed that at 6 months after ACL reconstruction, patients treated with continuous FNB had decreased isokinetic quadriceps strength, as well as decreased vertical and singleleg jump. Luo et al.26 elaborated on this, finding a deficit in isokinetic quadriceps extension strength, as well as slow and fast isokinetic flexion strength, in patients after FNB use in ACL reconstruction. Their study also concluded that a significantly higher percentage of patients in the LIA group met functional and isokinetic criteria for return to sports at 6 months when compared with the FNB group. In our study there were 2 instances of prolonged quadriceps weakness and 4 unresolved sensory disturbances in the FNB group, with 1 flexion contracture requiring reoperation in the LB group. Because of these possible complications with FNB, LIA with LB may be a potential alternative for pain control after ACL reconstruction. Patients receiving an FNB had a greater number of sleep disturbances the day of surgery and were also more likely to call their doctor the following day because of pain. These findings may be related to the rebound pain experienced after the FNB effects subside resulting in sleep disturbance, with the LB group having more consistent pain control the night of POD 0. Limitations This study does have potential limitations. The effect of the LIA may be dependent on injection and ACL reconstruction technique. We attempted to eliminate this potential bias by performing a single-surgeon study and creating a defined injection protocol. Second, double blinding of the study was not entirely possible. This was because FNB induces muscle paralysis and numbness. Moreover, blinding the surgeon was not required because the operating surgeon was not involved in the patient-reported outcomes or data collection. Patient knowledge of the treatment group may have led to cognitive bias. However, patients were told that neither treatment has been found to be superior and both treatments would provide adequate pain control. A blinded observer with no knowledge of patient randomization recorded data for statistical analysis to eliminate observer bias. A small percentage of patients with FNB have been shown to have nerve palsy or extended motor weakness after the block. The postoperative rehabilitation protocol was standardized in all patients. However, the effects were not discussed
LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
because this study only deals with acute pain (0-4 days) postoperatively. No patients started their rehabilitation program within the first week of the procedure. Finally, 3 different graft types were used for ACL reconstruction. This could potentially introduce a bias because of different surgical techniques performed in obtaining the grafts and final implantation. However, each treatment arm included a nearly identical number of patients with each graft type used.
Conclusions An increase in acute postoperative pain was found with LB compared with FNB for posteACL reconstruction pain control. After the acute postoperative period, there were no significant differences in opioid consumption or pain control. The occurrence of nerve irritation postoperatively was found to be higher in the FNB group.
Acknowledgment The authors thank their certified registered nurse anesthetists and nursing staff, as well as Senior Anesthesiologist Dr. Bruce Adelman, Dr. LaVonda Armstrong-Browder, and Dr. William Hightower, for their hard work and commitment throughout the study. They also thank John Korona and Chad Amato for their help in data collection.
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7. Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: Evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy 2010;26:894-900. 8. Choi S, McCartney CJ, van der Vyver M. Femoral nerve block does provide significant analgesia after anterior cruciate ligament reconstruction. Arthroscopy 2010;26: 1416, author reply 1417. 9. Fajardo M, Collins J, Landa J, Adler E, Meere P, Di Cesare PE. Effect of a perioperative intra-articular injection on pain control and early range of motion following bilateral TKA. Orthopedics 2011;34:354. 10. Lareau JM, Robbins CE, Talmo CT, Mehio AK, Puri L, Bono JV. Complications of femoral nerve blockade in total knee arthroplasty and strategies to reduce patient risk. J Arthroplasty 2012;27:564-568. 11. Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: A prospective, crossover, randomized clinical trial. J Arthroplasty 2012;27: 1234-1238. 12. Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty: A prospective, randomized trial. J Arthroplasty 2010;25: 851-857. 13. Banerjee P. The efficacy of multimodal high-volume wound infiltration in primary total knee replacement in facilitating immediate post-operative pain relief and attainment of early rehabilitation milestones. Eur J Orthop Surg Traumatol 2014;24:571-577. 14. Koh IJ, Chang CB, Seo ES, Kim SJ, Seong SC, Kim TK. Pain management by periarticular multimodal drug injection after anterior cruciate ligament reconstruction: A randomized, controlled study. Arthroscopy 2012;28: 649-657. 15. Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: A randomised controlled trial. Knee Surg Sports Traumatol Arthrosc 2014;22:317-323. 16. Essving P, Axelsson K, Kjellberg J, Wallgren O, Gupta A, Lundin A. Reduced morphine consumption and pain intensity with local infiltration analgesia (LIA) following total knee arthroplasty. Acta Orthop 2010;81: 354-360. 17. Ashraf A, Raut VV, Canty SJ, McLauchlan GJ. Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block. Knee 2013;20:324-327. 18. Barrington JW, Dalury DF, Emerson RH Jr, Hawkins RJ, Joshi GP, Stulberg BN. Improving patient outcomes through advanced pain management techniques in total hip and knee arthroplasty. Am J Orthop (Belle Mead NJ) 2013;42:S1-S20 (suppl). 19. Teng Y, Jiang J, Chen S, et al. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2014;22:1949-1957. 20. Lambrechts M, O’Brien MJ, Savoie FH, You Z. Liposomal extended-release bupivacaine for postsurgical analgesia. Patient Prefer Adherence 2013;7:885-890.
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21. Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of Exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty 2015;30:325-329. 22. Schulz KF, Altman DG, Moher DGroup C. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int J Surg 2011;9:672-677. 23. Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med 2001;38:633-638. 24. Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig 2013;33:109-115. 25. Krych A, Arutyunyan G, Kuzma S, Levy B, Dahm D, Stuart M. Adverse effect of femoral nerve blockade on quadriceps strength and function after ACL reconstruction. J Knee Surg 2015;28:83-88.
26. Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med 2015;43:331-336. 27. Kwofie MK, Shastri UD, Gadsden JC, et al. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: A blinded, randomized trial of volunteers. Reg Anesth Pain Med 2013;38:321-325. 28. Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacementdA word of caution. Knee 2009;16: 98-100. 29. Jaeger P, Zaric D, Fomsgaard JS, et al. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: A randomized, double-blind study. Reg Anesth Pain Med 2013;38:526-532.
Purpose: To compare femoral nerve block (FNB) versus local liposomal bupivacaine (LB) for pain control in patients undergoing anterior cruciate ligament (ACL) reconstruction. Methods: Eighty-five patients undergoing primary ACL reconstruction were assessed for participation. We performed a prospective randomized trial in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement. The study arms included either intraoperative local infiltration of LB (20 mL of bupivacaine/10 mL of saline solution) or preoperative FNB with a primary outcome of postoperative pain levels (visual analog scale) for 4 days. Secondary outcomes assessed included opioid consumption (intravenous morphine equivalents), hours slept, patient satisfaction, and calls to the physician. Randomization was by a computerized algorithm. The observer was blinded and the patient was not blinded to the intervention. Results: One patient declined participation; 2 patients were excluded after randomization. A total of 82 patients were analyzed. Outcomes showed a significant increase in pain in the LB group between 5 and 8 hours postoperatively (mean standard deviation, 6.3 2.0 versus 4.8 2.6; P ¼ .01). There were no significant differences between the groups in mean daily pain levels, morphine equivalents, or patient satisfaction when we controlled for graft type, age, body mass index, and sex. Patients receiving an FNB had a nonsignificant increase in number of sleep disturbances on the day of surgery (mean standard deviation, 4.4 3.7 v 3.1 2.1; P ¼ .09) and were more likely to call their doctor the following day because of pain (29% v 8%, P ¼ .04). Six patients in the FNB group had either prolonged quadriceps inhibition or sensory disturbance. One patient in the LB group required reoperation for a flexion contracture. Conclusions: An increase in acute postoperative pain was found with LB compared with FNB for posteACL reconstruction pain control. After the acute postoperative period, there were no significant differences in opioid consumption or pain control. The occurrence of nerve irritation postoperatively was found to be higher in the FNB group. Level of Evidence: Level I, prospective randomized trial.
P
erioperative pain control after anterior cruciate ligament (ACL) reconstruction is a significant issue that can affect patient satisfaction and outcomes.1,2 Over the past 2 decades, the use of femoral nerve blocks (FNBs) has provided added pain control in ACL
From the Department of Orthopaedic Surgery, Henry Ford Hospital (K.R.O., R.A.K., N.E.M., E.K.J., N.M., E.O., V.M.); and School of Medicine, Wayne State University (E.O.), Detroit, Michigan, U.S.A. The authors report that they have no conflicts of interest in the authorship and publication of this article. Received February 1, 2016; accepted May 23, 2016. Address correspondence to Kelechi R. Okoroha, M.D., Department of Orthopaedic Surgery, Henry Ford Hospital, 2799 W Grand Blvd (CFP-6), Detroit, MI 48202, U.S.A. E-mail: [email protected] Ó 2016 by the Arthroscopy Association of North America 0749-8063/16101/$36.00 http://dx.doi.org/10.1016/j.arthro.2016.05.033
reconstructions, which are now predominantly performed as outpatient procedures.3-6 An FNB, however, is not without side effects. Complications include nerve injury, partial motor block leading to delayed quadriceps activation, residual quadriceps weakness, and inadequate nerve block coverage of the donor site in hamstring autograft ACL reconstructions.7-10 Recently, orthopaedic procedures have used local infiltration anesthesia (LIA) as an alternative mode of pain control without the need for a regional block. Recent studies on patients undergoing ACL reconstruction and total knee arthroplasty have shown LIA, using a short-acting agent or multidrug cocktail, is an effective or better alternative to FNB in managing pain while allowing increased mobilization.3,11-17 Although LIA with short-acting anesthetics has shown possible benefit, the agents used in the multimodal drug cocktail
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Table 1. Demographic Data Randomization Group Patients, n Mean age, yr Sex Female Male BMI (SD) Concomitant procedures, n Meniscectomy Meniscal repair Chondroplasty Combination Total
Graft Type
FNB 41 27.0 (range, 16-53)
LB 41 27.6 (range, 16-53)
P Value .99 .74
17 24 26.0 (6.0)
16 25 26.5 (4.6)
.94 .58
4 7 0 4 15
12 1 1 6 20
.37
BTB 47 19.7 (range, 16-31)
HS 23 33.4 (range, 18-53)
PTA 12 45.9 (range, 37-53)
20 27 25.2 (4.9)
7 16 26.9 (4.3)
7 5 29.3 (7.6)
P Value .13 .001*
.13 .03*
BMI, body mass index; BTB, bone-tendon-bone; FNB, femoral nerve block; HS, hamstring; LB, liposomal bupivacaine; PTA, posterior tibialis allograft; SD, standard deviation. *Statistically significant.
have finite half-lives, after which patients can have increased pain.3,18,19 Liposomal bupivacaine (LB), a non-opioid local anesthetic (Exparel; Pacira Pharmaceuticals, Parsippany, NJ), was created to provide a longer-acting local infiltration anesthetic. LB combines bupivacaine within a multivesicular lipid-based delivery platform (DepoFoam; Pacira Pharmaceuticals) that allows the release of the anesthetic agent over an extended period.20 LB has seen increased use in orthopaedic procedures with randomized trials suggesting increased pain relief when compared with FNB in total knee arthroplasty.17,21 The purpose of our study was to compare FNB versus local LB for pain control in patients undergoing ACL reconstruction. Our hypothesis was that in patients undergoing ACL reconstruction, treatment with LB would lead to no significant difference in mean daily pain control.
Methods The CONSORT (Consolidated Standards of Reporting Trials) statement22 was followed to conduct this singlesurgeon, prospective, observer-blinded, randomized controlled trial. The study was reviewed and approved by our institutional review board (Henry Ford Hospital Investigation Review Board) and was registered at ClinicalTrials.gov (NCT02606448). From August 2014eApril 2015, 85 consecutive patients surgically treated by the senior author (V.M.) for ACL tears were assessed for study eligibility. Eighty-four patients were consented for participation. The inclusion criteria were patients aged older than 16 years and patients undergoing primary ACL reconstruction. The exclusion criteria were documented alcohol or drug abuse, revision ACL tear,
concurrent ligamentous injuries requiring repair, and allergies or intolerance to bupivacaine. All concomitant meniscal and cartilage procedures were recorded (Table 1). The data of patients who consented to be included in the study were compiled on a secure computer database. Patients were then randomized to receive either LIA or 1-shot FNB by adaptive randomization computer software (MD Anderson Cancer Center, Houston, TX). One week before surgical intervention, the surgeon (V.M.) and anesthesiologist were notified by secure email of the patient’s group designation for the upcoming week by the project coordinator. The study did not require physician blinding because patient outcomes were self-recorded. Patients then underwent an arthroscopically assisted ACL reconstruction with bonetendon-bone autograft, hamstring autograft, or posterior tibialis allograft through anatomic femoral and tibial tunnels. Each patient individually determined his or her choice of graft type after an informed discussion on potential options with his or her surgeon. The senior author (V.M.) treated all patients to increase the consistency of each procedure and injection technique. FNB Group In the FNB group, on the day of surgery, 1 hour before surgical intervention, patients received a preoperative ultrasound-guided single-shot FNB using 40 mL of 0.5% ropivacaine with an 80-mm, 22-gauge needle. This was combined with the use of a nerve stimulator to increase the accuracy of the block. Experienced senior anesthesiologists applied all FNBs in this study. LB Group For patients in the LB group, 20 mL of LB (266 mg) was mixed with 10 mL of saline solution to increase the
LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
volume to 30 mL total. This mixture was infiltrated locally using a standardized protocol after the graft had been secured and before closure of the wound. No mixture was injected intra-articularly. The injection protocol was as follows: A 60-mL syringe with a 1-inch, 18-gauge needle was used to administer the injection. Infiltration of 20 mL was performed in 5-mL increments evenly into the graft site. In the bone-tendon-bone group, injection was performed at the bone harvest sites at the patella and tibia, as well as the periosteum. In the hamstring graft group, infiltration was performed in the soft tissues around the donor site, as well as proximally at the muscle transection site, with the use of a Foley catheter led along the tendon stripper to reach the proximal muscle. In the posterior tibialis graft group, the injection was distributed evenly between soft-tissue dissection sites. In each group neither the bone tunnels nor the graft itself was infiltrated with LB, to decrease the chances of intra-articular infiltration. The remaining 10 mL was infiltrated into the portal and incision sites evenly. Data Collection After surgery, patients were taken to the postoperative care unit, where initial opioid consumption and visual analog scale (VAS) pain scores were recorded every hour by nursing staff. Medications were standardized so that patients received 0.5 mg of hydromorphone hydrochloride every 10 minutes as needed for pain, with a maximum of 5 doses. Patients were then discharged home the day of surgery with a prescription for 60 tablets of 5 mg of hydrocodonee325 mg of acetaminophen and instructed to take 1 to 2 tablets every 4 to 6 hours as needed for pain. Because LB has a potential effectiveness of 72 hours, patients were given a pain diary binder to fill out for 4 days postoperatively, starting with the day of surgery. The pain diary allowed patients to maintain a record of their pain and opioid consumption every 4 hours. The diary also asked the patients about any side effects from the medication, as well as if they were awoken from sleep because of pain overnight and, if so, how many times. Finally, patients were asked if they had to contact their doctor’s office because of pain and if they were satisfied with their pain management. After retrieval of patients’ pain diaries, a blinded observer (E.O.) recorded outcome measures. Before statistical analysis, opioid consumption between the control and study groups was converted to intravenous morphine equivalents. This was done to convert the different opioid medications used to one factor that could be cumulated and compared directly between the groups. VAS (10-cm scale) measurements were converted to a 0- to 10-point pain rating scale.
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Statistical Analysis The primary endpoint of this study was a mean daily pain difference on a VAS of 13 mm between the FNB and LB groups. This was based on previous data showing that a difference of 13 mm on a VAS represents, on average, the minimum change in acute pain that is clinically significant.23 A power analysis was performed before the study to assess the primary hypothesis that a significant difference in mean daily pain of 13 mm on the VAS will not be found between the FNB and LB groups. With a power of 80% (b level ¼ .80, a level ¼ .05), a sample size of 25 patients per group was obtained. A sample size of 85 patients (42 per group) was selected to allow for incomplete data collection. Secondary outcomes assessed included mean intravenous morphine equivalents used, number of sleep disturbances, satisfaction with pain management, and calls to the physician because of pain. All data were collected and analyzed using R 3.2.1 software (R Core Team, 2012 [R Foundation for Statistical Computing, Vienna, Austria]). Statistical comparisons between the 2 groups regarding demographic variables, day-of-surgery raw VAS scores, and hours of sleep on each postoperative day (POD) were calculated with a 2-tailed Student t test using the mean and standard deviation of each measurement when appropriate. A preliminary test to confirm the quality of variances was conducted before using the t test to confirm the appropriate statistical analysis. We then performed a longitudinal analysis to analyze VAS scores and intravenous morphine equivalents, looking specifically at the interaction between time and the randomization group, while controlling for important covariates. To model these effects, we used multivariate generalized estimating equation models, modeling the unique effects of time, randomization group, and the interactions, while controlling for graft type, age, body mass index, and sex. A c2 test was used to compare pain satisfaction and a Fisher exact test was used to compare calls to the physician, concomitant procedures, and complications between the groups. In all analyses, P < .05 was considered statistically significant.
Results Group Demographic Characteristics Eighty-five consecutive patients surgically treated for the primary diagnosis of an ACL tear were assessed for participation in the study. One patient declined to participate and was not included. Eighty-four patients were subsequently randomized into 2 groups. Two patients who had magnetic resonance imaging evidence of an ACL tear did not undergo ACL reconstruction because of an incomplete ACL tear discovered by arthroscopy and were excluded after randomization.
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Enrollment
Assessed for eligibility (n= 85)
Not included (n= 1) Not meeting inclusion criteria (n= 0) Declined to participate (n= 1) Other reasons (n= 0)
Randomized (n= 84)
AllocaƟon Allocated to femoral nerve block (n=42) Received allocated intervention (n=41) Did not receive allocated intervention (Incomplete ACL tear on arthroscopy) (n=1)
Allocated to local liposomal bupivacaine (n=42) Received allocated intervention (n=41 ) Did not receive allocated intervention (Incomplete ACL tear on arthroscopy) (n=1)
Follow -Up Lost to follow-up (n=0) Discontinued intervention (n=0)
Lost to follow-up (n=0) Discontinued intervention (n=0)
Analysis Analyzed (n= 41) Excluded from analysis (n= 1)
Analyzed (n= 41) Excluded from analysis (n= 1)
Fig 1. CONSORT (Consolidated Standards of Reporting Trials) 2010 flow diagram. (ACL, anterior cruciate ligament.)
Data from the remaining 82 patients were included for further analysis (Fig 1). Baseline characteristics and concomitant procedures between the 2 groups are listed in Table 1. There were no statistical differences in any demographic characteristics between the 2 groups.
and 3 (P ¼ .99 and P ¼ .98, respectively) (Fig 6). Satisfaction with pain management was similar between the FNB and LB groups (Fig 7).
LB Versus FNB There was a significant increase in acute pain in the LB group between 5 and 8 hours postoperatively (mean standard deviation, 6.3 2.6 v 4.8 2.0; P ¼ .01) (Fig 2). However, when adjusted for covariates using generalized estimating equation models, there were no significant differences between mean pain levels and intravenous morphine equivalents between the LB and FNB groups on each POD (Figs 3 and 4). On evaluation of sleep patterns, we noted a nonsignificant increase in the number of sleep disturbances on POD 0 in patients receiving FNB compared with LB (mean standard deviation, 4.4 3.7 v 3.1 2.1; P ¼ .09). However, sleep disturbances were not significantly different between groups on POD 1, 2, and 3 (P ¼ .46, P ¼ .17, and P ¼ .29, respectively) (Fig 5). Patients in the FNB group were significantly more likely to call their doctor on POD 1 because of pain (28.6% v 7.5%, P ¼ .04). This value did not reach significance on POD 2
Mean Hourly Pain Levels Raw Data 8 7
p = .01
p = .06
p = .51
p = .38
p = .13
p = .06
Mean Pain Level VAS score
6 5 4
FNB
3
LB
2 1 0 0-4
5-8* 9-12 13 17-20 Time Following Surgery (in hours)
21-24
Fig 2. Raw mean hourly pain data, comparing pain levels between the 2 groups at 4-hour increments on the day of surgery. Patients in the liposomal bupivacaine (LB) group had a statistically significant increase in pain from 5-8 hours postoperatively (asterisk). (FNB, femoral nerve block; VAS, visual analog scale.)
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LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
Sleep quality Number of sleep disturbances
5 4.5 4 3
p = .17
2.5
p = .29
2 1.5 1 0.5 0
In our evaluation of postoperative complications, 2 patients in the FNB group had prolonged quadriceps inhibition. One patient had return of quadriceps function at 10 weeks and the other had resolution at 4 months with residual pain. Four patients in the FNB group had prolonged sensory disturbance in the anterior proximal thigh, which persisted in all cases at an average follow-up of 6 months. One patient in the LB group had a flexion contracture that required arthroscopic debridement of a cyclops lesion. The difference in postoperative complications between the 2 groups was
p = .46
3.5
FNB LB
Fig 3. Predicted average pain levels, averaged across patients, stratified by time interval and randomization group, while controlling for graft type, age, body mass index, and sex. There were no significant differences between the groups in predicted average pain levels when controlling for covariates. (FNB, femoral nerve block; LB, liposomal bupivacaine; VAS, visual analog scale.)
p = .09
Day 0 4.4 3.1
Day 1 3.0 2.6
Day 2 2.2 1.6
Day 3 1.6 1.2
Fig 5. Comparison of number of sleep disruptions caused by pain in patients treated with femoral nerve block (FNB) versus liposomal bupivacaine (LB) by postoperative day. No significant differences were found; however, there was a trend toward increased number of sleep disturbances on the day of surgery in the FNB group.
not statistically significant (P ¼ .06). No intraoperative complications occurred in either group.
Discussion In our evaluation of the use of LIA with LB for pain control after ACL reconstruction, the results suggest that patients treated with LB have increased pain levels in the initial postoperative hours when compared with FNB. However, after the acute postoperative period, LB provides similar pain control after ACL reconstruction when compared with FNB without the inherent risks associated with nerve blockade procedures. We also found that LB improved early sleep quality and the
35.0% 30.0%
Percentage of patients contacting the surgeon p = .04
25.0% 20.0% 15.0% p = .99
p = .98
10.0% 5.0% 0.0%
Fig 4. Predicted total medication taken, averaged across patients, stratified by time interval and randomization group, while controlling for graft type, age, body mass index, and sex. There were no significant differences between the groups in predicted total medication taken when controlling for covariates. (FNB, femoral nerve block; LB, liposomal bupivacaine.)
FNB LB
Day 1* 28.6% 7.5%
Day 2 2.9% 2.5%
Day 3 6.5% 3.1%
Fig 6. Comparison of percentage of patients who contacted their physician because of pain by day after anterior cruciate ligament reconstruction. Patients in the femoral nerve block (FNB) group were more likely to call their physician the day after surgery because of pain. An asterisk indicates a significant difference. (LB, liposomal bupivacaine.)
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Patient Satisfaction
100.0% 90.0% Mean Percent Satisfied
80.0% 70.0%
p = .19
p = .99
Day 2 68.8% 84.6%
Day 3 87.5% 90.3%
p = .62 p = .81
60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% FNB LB
Day 0 51.4% 57.1%
Day 1 54.6% 63.2%
Fig 7. Comparison of patient satisfaction with pain control by day after anterior cruciate ligament reconstruction. There was no significant difference in patient satisfaction between the 2 groups. (FNB, femoral nerve block; LB, liposomal bupivacaine.)
number of calls to the physician related to rebound pain. LIA versus FNB for pain control after ACL reconstruction has previously been evaluated, with the use of short-acting pain medications for LIA.14,15 Kristensen et al.15 evaluated 60 patients for 48 hours after randomization to FNB versus LIA with ropivacaine. They found no significant differences between the groups in pain intensity or total opioid consumption. Beyond differences in multiple surgical techniques, this study was limited in the length and frequency of pain control evaluated, as well as lack of evaluation of the effect of the pain control regimen on sleep and patient satisfaction. Our study found similar results with the use of LB for pain control with expanded evaluation of temporal pain control, adding to evidence of the usefulness of long-acting LIA for pain control after orthopaedic procedures. Although LB showed no significant differences compared with FNB regarding mean daily pain relief, there was an initial 12-hour period in which patients in the LB group had increased pain when compared with the FNB group according to raw data. This was thought to be caused by the reported 10-hour lag time before optimal local concentration of LB, resulting from the delayed release from lipid storage delivery.24 Previous studies have not determined how long it takes for patients to begin to have comparable pain relief after injection of LB. Surdam et al.21 presented evidence that patients treated with LB when undergoing unilateral total knee arthroplasty have increased pain the day of surgery when compared with FNB; however, their study did not determine specifically when, during the day of the operation, patients had increased pain. Our study suggests that there may be an increase in pain in patients treated with LB compared with FNB in the first
12 hours after surgery. After this period, pain levels begin to balance out and are not significantly different. This finding suggests that patients undergoing LIA with LB could potentially benefit from supplemental analgesics to cover the acute period postoperatively. The deleterious effects of FNB have been implicated in various studies.10,25-29 Krych et al.25 evaluated the effect of FNB on quadriceps strength and function after ACL reconstruction. Their results showed that at 6 months after ACL reconstruction, patients treated with continuous FNB had decreased isokinetic quadriceps strength, as well as decreased vertical and singleleg jump. Luo et al.26 elaborated on this, finding a deficit in isokinetic quadriceps extension strength, as well as slow and fast isokinetic flexion strength, in patients after FNB use in ACL reconstruction. Their study also concluded that a significantly higher percentage of patients in the LIA group met functional and isokinetic criteria for return to sports at 6 months when compared with the FNB group. In our study there were 2 instances of prolonged quadriceps weakness and 4 unresolved sensory disturbances in the FNB group, with 1 flexion contracture requiring reoperation in the LB group. Because of these possible complications with FNB, LIA with LB may be a potential alternative for pain control after ACL reconstruction. Patients receiving an FNB had a greater number of sleep disturbances the day of surgery and were also more likely to call their doctor the following day because of pain. These findings may be related to the rebound pain experienced after the FNB effects subside resulting in sleep disturbance, with the LB group having more consistent pain control the night of POD 0. Limitations This study does have potential limitations. The effect of the LIA may be dependent on injection and ACL reconstruction technique. We attempted to eliminate this potential bias by performing a single-surgeon study and creating a defined injection protocol. Second, double blinding of the study was not entirely possible. This was because FNB induces muscle paralysis and numbness. Moreover, blinding the surgeon was not required because the operating surgeon was not involved in the patient-reported outcomes or data collection. Patient knowledge of the treatment group may have led to cognitive bias. However, patients were told that neither treatment has been found to be superior and both treatments would provide adequate pain control. A blinded observer with no knowledge of patient randomization recorded data for statistical analysis to eliminate observer bias. A small percentage of patients with FNB have been shown to have nerve palsy or extended motor weakness after the block. The postoperative rehabilitation protocol was standardized in all patients. However, the effects were not discussed
LIPOSOMAL BUPIVACAINE V FEMORAL NERVE BLOCK
because this study only deals with acute pain (0-4 days) postoperatively. No patients started their rehabilitation program within the first week of the procedure. Finally, 3 different graft types were used for ACL reconstruction. This could potentially introduce a bias because of different surgical techniques performed in obtaining the grafts and final implantation. However, each treatment arm included a nearly identical number of patients with each graft type used.
Conclusions An increase in acute postoperative pain was found with LB compared with FNB for posteACL reconstruction pain control. After the acute postoperative period, there were no significant differences in opioid consumption or pain control. The occurrence of nerve irritation postoperatively was found to be higher in the FNB group.
Acknowledgment The authors thank their certified registered nurse anesthetists and nursing staff, as well as Senior Anesthesiologist Dr. Bruce Adelman, Dr. LaVonda Armstrong-Browder, and Dr. William Hightower, for their hard work and commitment throughout the study. They also thank John Korona and Chad Amato for their help in data collection.
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26. Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med 2015;43:331-336. 27. Kwofie MK, Shastri UD, Gadsden JC, et al. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: A blinded, randomized trial of volunteers. Reg Anesth Pain Med 2013;38:321-325. 28. Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacementdA word of caution. Knee 2009;16: 98-100. 29. Jaeger P, Zaric D, Fomsgaard JS, et al. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: A randomized, double-blind study. Reg Anesth Pain Med 2013;38:526-532.