Study of EXPAREL in Patients Undergoing Breast Augmentation

NCT01582490 | Completed Phase 4 Results

• 1 other identifier: MA402S23B901
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Mammoplasty; Postoperative Pain

Keywords

Mammoplasty; Postoperative pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.

  10 days

Secondary Outcomes (7)

• Total Postsurgical Opioid Consumption in the Surgical Center

  10 days

• Pain Intensity Assessment Upon Waking in the PACU

  Upon waking in the PACO post surgery

• Pain Intensity Assessment at the Time of Hospital Discharge

  At the time of hospital discharge

• Time to Hospital Discharge Being Written

  At the time of hospital discharge

• Incidence of Opioid-Related Adverse Events

  Through 10 Days Post Surgery

Study Arms (2)

Infiltration - EXPAREL

ACTIVE COMPARATOR

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.

Drug: Instillation - EXPAREL

Instillation - EXPAREL

EXPERIMENTAL

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.

Drug: Infiltration - EXPAREL

Interventions

Instillation - EXPAREL DRUG

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

Also known as: bupivacaine liposomal injectable suspension

Infiltration - EXPAREL

Infiltration - EXPAREL DRUG

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

Also known as: bupivacaine liposomal injectable suspension

Instillation - EXPAREL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Erol Onel, MD
• Organization: Pacira Pharmaceuticals, Inc.

erol.onel@pacira.com

858-625-2424

Study Officials

• Daniel Del Vecchio, MD

  Steward Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-05

Locations

US (1)