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Study of EXPAREL in Patients Undergoing Breast Augmentation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582490
First Posted: April 20, 2012
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Duration of Analgesia [ Time Frame: 10 days ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: April 29, 2014
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014
Last Verified: May 2014

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