Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

Phase 3 Terminated 136 enrolled Pacira Pharmaceuticals, Inc

RandomizedParallel-groupDouble-blindSupportive care

Summary

The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Timeline

Start: 2008-11
Primary completion: 2009-02
Completion: 2009-02

Publications

Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	200 mg	Other
Subject	SKY0402	Unknown	600 mg	Other

Indications

No indication recorded.