Study of EXPAREL in Patients Undergoing Breast Augmentation

NCT ID: NCT01582490

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-11-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infiltration - EXPAREL

Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.

Group Type: ACTIVE_COMPARATOR

Instillation - EXPAREL

Intervention Type: DRUG

Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Instillation - EXPAREL

Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.

Group Type: EXPERIMENTAL

Infiltration - EXPAREL

Intervention Type: DRUG

IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Interventions

Instillation - EXPAREL

Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Intervention Type: DRUG

Infiltration - EXPAREL

IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposomal injectable suspension; bupivacaine liposomal injectable suspension

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Del Vecchio, MD

Role: PRINCIPAL_INVESTIGATOR

Steward Research

Locations

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Countries

United States

Other Identifiers

MA402S23B901

Identifier Type: -

Identifier Source: org_study_id