Study of EXPAREL in Patients Undergoing Breast Augmentation

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Female, 18-75 years of age inclusive.

• American Society of Anesthesiologists (ASA) physical status 1-3.

• Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).

• Physically and mentally able to participate in the study and complete all study assessments.

• Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.

Exclusion Criteria:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.

• Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.

• Subjects currently pregnant or who may become pregnant during the course of the study.

• Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.

• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.