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Study of EXPAREL in Patients Undergoing Breast Augmentation

Information source: Pacira Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Augmentation

Intervention: Opioid (Drug); Opioid (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pacira Pharmaceuticals, Inc

Official(s) and/or principal investigator(s):
Daniel Del Vecchio, MD, Principal Investigator, Affiliation: Steward Research

Overall contact:
Jocelyn Wisse, Email: jocelyn.wise@steward.org

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 Details

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

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

Primary outcome: Duration of analgesia

Secondary outcome:

Efficacy measures of EXPAREL.

Safety Assessment

Detailed description: Each subject will undergo bilateral augmentation mammoplasty and will receive the same dose of EXPAREL. This primary objective of this study is to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives are to further assess other efficacy measures and the safety profile of EXPAREL.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female, 18-75 years of age inclusive.

- American Society of Anesthesiologist (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.

Locations and Contacts

Jocelyn Wisse, Email: jocelyn.wise@steward.org

Steward St. Elizabeth's Medical Center, Brighton, Massachusetts 02135, United States; Recruiting
Jocelyn Wise, Email: jocelyn.wise@steward.org
Max Shapiro, Email: max.shapiro@steward.org
Daniel Del Vecchio, MD, Principal Investigator
Andrew Sternlicht, MD, Sub-Investigator
Additional Information

Starting date: April 2012
Last updated: July 7, 2012

Page last updated: February 07, 2013

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