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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.

Abstract

BACKGROUND
Bupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.
OBJECTIVE
The 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.
DESIGN
This evaluation was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 study.
SETTINGS
Data were obtained from 13 centers in the Republic of Georgia, Poland, and Serbia.
PATIENTS
Included in this study were patients aged 18 to 86 years undergoing excisional hemorrhoidectomy.
INTERVENTIONS
All patients received either a single dose of bupivacaine extended-release 300 mg or placebo administered intraoperatively via wound infiltration.
MAIN OUTCOME MEASURE
The cumulative pain score was assessed by measurement of the area under the curve of pain intensity through 72 hours after study drug administration.
RESULTS
One 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.
CONCLUSIONS
Bupivacaine 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.

Links

  • Publisher Full Text
  • Authors

    Gorfine SR, Onel E, Patou G, Krivokapic ZV

    Source

    Diseases of the colon and rectum 54:12 2011 Dec pg 1552-9

    MeSH

    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Anesthetics, Local
    Bupivacaine
    Delayed-Action Preparations
    Double-Blind Method
    Female
    Hemorrhoids
    Humans
    Liposomes
    Male
    Middle Aged
    Pain Measurement
    Pain, Postoperative
    Patient Satisfaction
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Clinical Trial, Phase III
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22067185