702: EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

Sponsor
Pacira Pharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01801124
Collaborator
(none)
13
1
1
8
1.6

Study Details

Study Description

Brief Summary

Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: EXPAREL

undiluted EXPAREL 266 mg

Drug: EXPAREL
single dose 266 mg of undiluted EXPAREL
Other Names:
  • bupivacaine liposome injectable suspension
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Postsurgical Analgesic Use [10 days]

      The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)

    Secondary Outcome Measures

    1. Postsurgical AEs and SAEs Through Day 30. [30 days]

      Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.

    • Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.

    • Abdominal incision length of 3-12 cm.

    • Subjects must be physically and mentally able to participate in the study and complete all study assessments.

    • Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

    Exclusion Criteria:
    • History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

    • Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.

    • Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.

    • Any subject, who in the opinion of the Investigator, is on chronic pain medicine.

    • Any female subject who is currently pregnant.

    • 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

    Locations

    Site City State Country Postal Code
    1 Maimonides Medical Center Brooklyn New York United States 11219

    Sponsors and Collaborators

    • Pacira Pharmaceuticals, Inc

    Investigators

    • Principal Investigator: Mark Kronenfeld, MD, Maimonides

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pacira Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT01801124
    Other Study ID Numbers:
    • MA402S23B702
    First Posted:
    Feb 28, 2013
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Pacira Pharmaceuticals, Inc
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA.
    Pre-assignment Detail Subjects were not excluded.
    Arm/Group Title EXPAREL
    Arm/Group Description All subjects received a total of 266mg EXPAREL (bupicavaine liposome injectable suspension) diluted with preservative-free 0.9% normal saline to a volume of 30mL. Study drug was to be administered with ultrasound guidance by injection through a needle or catheter into the tissue plane between the transversus abdominis and internal oblique muscles of the abdominal wall.
    Period Title: Overall Study
    STARTED 13
    COMPLETED 13
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title EXPAREL
    Arm/Group Description undiluted EXPAREL 266 mg
    Overall Participants 13
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    13
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.7
    (12.72)
    Sex: Female, Male (Count of Participants)
    Female
    3
    23.1%
    Male
    10
    76.9%
    Region of Enrollment (participants) [Number]
    United States
    13
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Postsurgical Analgesic Use
    Description The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
    Time Frame 10 days

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised all enrolled subjects.
    Arm/Group Title EXPAREL
    Arm/Group Description Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
    Measure Participants 13
    Mean (Standard Deviation) [mg (morphine equivalents)]
    9.7
    (17.41)
    2. Secondary Outcome
    Title Postsurgical AEs and SAEs Through Day 30.
    Description Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised all enrolled subjects.
    Arm/Group Title EXPAREL
    Arm/Group Description Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
    Measure Participants 13
    Number [AEs]
    0

    Adverse Events

    Time Frame Through Day 30
    Adverse Event Reporting Description Adverse events were collected by the investigator from the time of signing the informed consent form through 30 days post surgery.
    Arm/Group Title EXPAREL
    Arm/Group Description Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
    All Cause Mortality
    EXPAREL
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    EXPAREL
    Affected / at Risk (%) # Events
    Total 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    EXPAREL
    Affected / at Risk (%) # Events
    Total 0/13 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Mark Kronefeld, MD
    Organization Maimonides Medical Center
    Phone (718) 283-8816
    Email
    Responsible Party:
    Pacira Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT01801124
    Other Study ID Numbers:
    • MA402S23B702
    First Posted:
    Feb 28, 2013
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Feb 1, 2021