Study of EXPAREL in Patients Undergoing Breast Augmentation - Full Text View

Purpose

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).

Condition	Intervention	Phase
Mammoplasty Postoperative Pain	Drug: Instillation - EXPAREL Drug: Infiltration - EXPAREL	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

Duration of analgesia [ Time Frame: 10 days ] [ Designated as safety issue: No ]
The primary outcome measure is the duration of analgesia, measured by the time from the end surgery to the subject's first postsurgical opioid administration.

Secondary Outcome Measures:

Efficacy measures of EXPAREL. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Postsurgical assessments will include:
- Date, time, amount, and route of all opioid and non-opioid analgesics administered in the surgical center.
- Subject's assessment of pain intensity using a numeric rating scale (NRS) upon waking in the post-anesthesia care unit (PACU) and at time of hospital discharge
- Date and time the hospital discharge order is written.
- Overall subject satisfaction with postsurgical pain control (using a 5-point Likert scale) at the time of hospital discharge and at the Day 10 visit.
Safety Assessment [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Postsurgical safety assessments will include adverse events (AEs) and serious adverse events (SAEs).

Enrollment:	19
Study Start Date:	April 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Drug: Instillation - EXPAREL Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. Other Name: bupivacaine liposomal injectable suspension
Experimental: 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.	Drug: Infiltration - EXPAREL IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. Other Name: bupivacaine liposomal injectable suspension

Arms

Assigned Interventions

Active Comparator: 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.

Drug: Instillation - EXPAREL

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

Other Name: bupivacaine liposomal injectable suspension

Experimental: 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.

Drug: Infiltration - EXPAREL

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

Other Name: bupivacaine liposomal injectable suspension

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582490

Locations

United States, Massachusetts
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

Principal Investigator:

Daniel Del Vecchio, MD

Steward Research

More Information

No publications provided

Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01582490 History of Changes
Other Study ID Numbers:	MA402S23B901
Study First Received:	April 19, 2012
Last Updated:	May 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

Mammoplasty
Postoperative pain
Analgesia

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013