NCT02574520

Trial of Extended Release Bupivacaine for Pain Relief After Surgery

A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	SABER-Bupivacaine (Part 1)	5 ml once at end of surgery
DRUG	SABER-Bupivacaine (Part 2)	5 ml once at end of surgery
DRUG	Saline Placebo	5 ml once at end of surgery
DRUG	Bupivacaine HCl	0.5%, 15 ml, once at end of surgery

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2015-10-14
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study