A Phase 3 Active-Controlled Trial of Liposomal Bupivacaine via Adductor Canal Block for Total Knee Arthroplasty
Abstract
BACKGROUND
The efficacy, safety, pharmacokinetics, and pharmacodynamics of liposomal bupivacaine combined with bupivacaine hydrochloride administered via adductor canal block for total knee arthroplasty were evaluated.
METHODS
This randomized, double-blind, active-controlled, multicenter trial (NCT05139030) enrolled adults undergoing primary unilateral total knee arthroplasty. Participants were randomized 1:1 to receive an adductor canal block administered as a single dose of liposomal bupivacaine 133 mg admixed with bupivacaine hydrochloride 50 mg (liposomal bupivacaine group) or bupivacaine hydrochloride 50 mg admixed with saline (bupivacaine group). The study enrolled 167 participants (liposomal bupivacaine group, n = 85; bupivacaine group, n = 82). The primary endpoint was the area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores from zero to 96 hours postsurgery.
RESULTS
From zero to 96 hours after surgery, the least squares mean (SE) of the AUC of the NRS pain intensity score was lower in the liposomal bupivacaine group (568.9 [20.07]) versus the bupivacaine group (634.7 [20.04]) (least squares mean difference versus bupivacaine, -65.8 [95% CI (confidence interval), -118.7 to -12.9]; P = 0.0074). In the liposomal bupivacaine group, total opioid consumption was lower from zero to 96 hours versus the bupivacaine group (least squares mean [95% CI], 101.8 [89.1 to 116.3] versus 132.8 [116.3 to 151.7] morphine milligram equivalents; least squares…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 167 participants or records.
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