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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

Gorfine, Stephen R. M.D.1; Onel, Erol M.D.2; Patou, Gary M.D.2; Krivokapic, Zoran V. M.D., Ph.D.3

doi: 10.1097/DCR.0b013e318232d4c1
Original Contribution

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: srgny@nyc.rr.com

© The ASCRS 2011