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

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Trial Conditions
  • Breast Augmentation
  • Mammoplasty
  • Postoperative Pain
What is the purpose of this trial?

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).

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 75 

Gender:
Female

Eligibility

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.

Gender: Female
Steward Physician(s)
  • Daniel Del Vecchio, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • Instillation - EXPAREL
  • Infiltration - EXPAREL
Physician Researcher

Investigator Name:

  • Daniel Del Vecchio, MD

Other Information

Sponsor: Pacira Pharmaceuticals, Inc
Phase: Phase 4
Trial ID: NCT01582490
Volunteers:  Not Accepting Healthy Volunteers

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