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Trial record 15 of 418 for:    "abdominal wall defect" OR "Hernia, Abdominal"

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 28, 2013
Last Update Posted: September 11, 2013
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
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

Condition Intervention Phase
Hernia Drug: EXPAREL Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use [ Time Frame: 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:
  • The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30. [ Time Frame: 30 days ]
    Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.

Enrollment: 13
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EXPAREL
undiluted EXPAREL 266 mg
single dose 266 mg of undiluted EXPAREL
Other Name: bupivacaine liposome injectable suspension

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.

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:   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
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): NCT01801124

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Principal Investigator: Mark Kronenfeld, MD Maimonides
  More Information

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01801124     History of Changes
Other Study ID Numbers: MA402S23B702
First Submitted: February 26, 2013
First Posted: February 28, 2013
Results First Submitted: July 2, 2013
Results First Posted: September 11, 2013
Last Update Posted: September 11, 2013
Last Verified: July 2013

Keywords provided by Pacira Pharmaceuticals, Inc:
hernia repair

Additional relevant MeSH terms:
Hernia, Abdominal
Pathological Conditions, Anatomical