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 (hours) from the end surgery to the subject's first postsurgical opioid administration.

Secondary Outcome Measures:

Total Postsurgical Opioid Consumption in the Surgical Center [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
Pain Intensity Assessment Upon Waking in the PACU [ Time Frame: Upon waking in the PACO post surgery ] [ Designated as safety issue: Yes ]
Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.
Pain Intensity Assessment at the Time of Hospital Discharge [ Time Frame: At the time of hospital discharge ] [ Designated as safety issue: Yes ]
Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.
Time to Hospital Discharge Being Written [ Time Frame: At the time of hospital discharge ] [ Designated as safety issue: Yes ]
The time (hours) to the hospital discharge being written for subjects in each group,
Incidence of Opioid-Related Adverse Events [ Time Frame: Through 10 Days Post Surgery ] [ Designated as safety issue: Yes ]
The incidence of adverse events that were assessed as opioid-related
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge [ Time Frame: At the time of hospital discharge ] [ Designated as safety issue: Yes ]
Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 [ Time Frame: Day 10 after surgery ] [ Designated as safety issue: Yes ]
Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."


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 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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01582490 History of Changes
Other Study ID Numbers:	MA402S23B901
Study First Received:	April 19, 2012
Results First Received:	April 29, 2014
Last Updated:	May 31, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:


Mammoplasty Postoperative pain Analgesia

Additional relevant MeSH terms:


Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms	Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 27, 2016