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Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial.
BACKGROUNDBupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.
OBJECTIVEThe aim of this study was to compare the magnitude and duration of postoperative analgesia from a single dose of bupivacaine extended-release injection with placebo administered intraoperatively in patients undergoing hemorrhoidectomy.
DESIGNThis evaluation was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 study.
SETTINGSData were obtained from 13 centers in the Republic of Georgia, Poland, and Serbia.
PATIENTSIncluded in this study were patients aged 18 to 86 years undergoing excisional hemorrhoidectomy.
INTERVENTIONSAll patients received either a single dose of bupivacaine extended-release 300 mg or placebo administered intraoperatively via wound infiltration.
MAIN OUTCOME MEASUREThe cumulative pain score was assessed by measurement of the area under the curve of pain intensity through 72 hours after study drug administration.
RESULTSOne hundred eighty-nine patients were randomly assigned and treated; 186 completed the study. Pain intensity scores were significantly lower in the bupivacaine extended-release group in comparison with the group receiving placebo (141.8 vs 202.5, P < .0001). More patients in the bupivacaine extended-release group remained opioid free from 12 hours (59%) to 72 hours (28%) after surgery compared with patients receiving placebo (14% and 10%; P < .0008 through 72 h). The mean total amount of opioids consumed through 72 hours was 22.3 mg and 29.1 mg in the bupivacaine extended-release and placebo groups (P ≤ .0006). The median time to first opioid use was 14.3 hours in the bupivacaine extended-release group vs 1.2 hours in the placebo group (P < .0001). A greater proportion of patients in the bupivacaine extended-release group were satisfied with their postsurgical analgesia (95% vs 73%, P = .0007) than in the placebo group.
CONCLUSIONSBupivacaine extended-release demonstrated a statistically significant reduction in pain through 72 hours, decreased opioid requirements, delayed time to first opioid use, and improved patient satisfaction compared with placebo after hemorrhoidectomy.
Diseases of the colon and rectum 54:12 2011 Dec pg 1552-9
Aged, 80 and over
Pub Type(s)Clinical Trial, Phase III
Randomized Controlled Trial
Research Support, Non-U.S. Gov't