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

Phase 2 Completed 60 enrolled Durect Nycomed · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-12
Primary completion: 2009-10
Completion: 2009-10

Outcome

Missed primary endpoint

registry p = 0.303; LS Mean Difference -0.64 (95% CI -1.74 to 0.47) NCT00818363 ↗

registry p = 0.303; LS Mean Difference -10.25 (95% CI -30.04 to 9.55) NCT00818363 ↗

Publications

Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	5 ml	Other

Indications

No indication recorded.