Study of EXPAREL in Patients Undergoing Breast Augmentation

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01582490
Study type	Interventional
Source	Pacira Pharmaceuticals, Inc
Contact
Status	Completed
Phase	Phase 4
Start date	April 2012
Completion date	November 2012

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