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.
1 The Mount Sinai Medical Center, New York, New York
2 Pacira Pharmaceuticals, Inc, Parsippany, New Jersey
3 Clinic for Digestive Surgery, University Clinical Center of Serbia, Belgrade, Serbia
Funding/Support: Pacira Pharmaceuticals, Inc.
Financial Disclosures: None reported.
Poster presentation at the meeting of the Society of Coloproctology of Yugoslavia, Belgrade, Serbia, October 7 to 9, 2010, and the meeting of The American Society of Colon and Rectal Surgeons, Vancouver, British Columbia, Canada, May 14 to 18, 2011.
Correspondence: Stephen R. Gorfine, M.D., The Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10029-6574. E-mail: firstname.lastname@example.org