Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty

Abstract

Background The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty. Methods Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0–72) with imputed scores after rescue medication. Results In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0–72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively). Conclusion FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.

Pain Control in Total Knee Arthroplasty

“…1,69 Currently, research is being performed looking at the efficacy and safety of liposomal bupivacaine in peripheral nerve blocks, with the available data demonstrating promising significant advantages in accomplishing prolonged postoperative analgesia. 8,73,[77][78][79]…”

“…In a two-part clinical study designed to meet the United States Food and Drug Administration standard for approval of analgesic agents, FNB with liposomal bupivacaine after TKA resulted in modestly reduced average pain and opioid use in the first 72 hours after surgery compared with placebo. 8 Wang et al 72 evaluated 341 TKA patients who received either an ACB with liposomal bupivacaine or a ropivacaine pain ball. The liposomal bupivacaine group had significantly lower pain scores at 36 hours postoperatively compared with the ropivacaine group (3.1 vs. 4l points; p < 0.001), as well as lower opioid use, although this was not significant (115 vs. 173 mg; p ¼ 0.08).…”

Anesthesia and Analgesia Practice Pathway Options for Total Knee Arthroplasty

“…99 A phase 3, multicenter RCT demonstrated a treatment effect of at least 72 hours in subjects undergoing TKA, with statistically and clinically relevant analgesic benefits provided versus placebo up to 24 hours (minimal differences at time points after 24 hours). 100 Comparisons with a single-injection or continuous FNB are lacking but will be required to demonstrate the relevance of liposome bupivacaine FNBs if such a formulation is ultimately approved by the US Food and Drug Administration.…”

CORR Insights®: No Difference in Early Analgesia Between Liposomal Bupivacaine Injection and Intrathecal Morphine After TKA

“…Since femoral nerve block is not superior to PAI and even less superior to continuous PAI, we are left with one strategy that might be of interest for using liposomal bupivacaine: The use of repeated injections of liposomal bupivacaine-based PAI (Exparel) in either femoral nerve block [8] or adductor canal block [7], which was proven to be safe [10]. Another option would be to use an intraarticular catheter with repeated injections of extended release of liposomal bupivacaine to improve pain relief without motor blockade.…”