Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of EXPAREL in Patients Undergoing Breast Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01582490
First received: April 19, 2012
Last updated: May 31, 2014
Last verified: May 2014
  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:


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

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
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

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
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
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014