At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)
In Brief
A Phase 3 clinical trial evaluating SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2), and 2 other interventions for Post Operative Pain. Completed, enrolled 399 participants across 21 sites.
Detailed Summary
This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound. The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).
Study Details
Timeline
Interventions
5 ml once at end of surgery
5 ml once at end of surgery
5 ml once at end of surgery
0.5%, 15 ml, once at end of surgery