NCT01582490

Study of EXPAREL in Patients Undergoing Breast Augmentation

Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).

Detailed description

Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.

Conditions

• Mammoplasty
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Instillation - EXPAREL	Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
DRUG	Infiltration - EXPAREL	IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-04-20
• Last updated: 2014-07-02
• Results posted: 2014-07-02

Locations

1 site across 1 country: United States