Study of EXPAREL in Patients Undergoing Breast Augmentation

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Mammoplasty
• Intervention / Treatment: Drug: Instillation - EXPAREL; Drug: Infiltration - EXPAREL

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: bupivacaine liposomal injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postsurgical Opioid Consumption in the Surgical Center	Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.	10 days
Pain Intensity Assessment Upon Waking in the PACU	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.	Upon waking in the PACO post surgery
Pain Intensity Assessment at the Time of Hospital Discharge	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.	At the time of hospital discharge
Time to Hospital Discharge Being Written	The time (hours) to the hospital discharge being written for subjects in each group,	At the time of hospital discharge
Incidence of Opioid-Related Adverse Events	The incidence of adverse events that were assessed as opioid-related	Through 10 Days Post Surgery
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."	At the time of hospital discharge
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10	Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."	Day 10 after surgery

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Daniel Del Vecchio, MD, Steward Research

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: May 31, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Analgesia; Postoperative pain; Mammoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MA402S23B901