NCT00818363

A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	SABER-Bupivacaine	Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
DRUG	SABER-Placebo	Injectable Solution; 5.0 mL SABER-Placebo/Once

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-01-07
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

9 sites across 2 countries: Australia, New Zealand