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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01801124
First received: February 26, 2013
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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: 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® 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Drug: EXPAREL
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01801124

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

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01801124     History of Changes
Other Study ID Numbers: MA402S23B702
Study First Received: February 26, 2013
Results First Received: July 2, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
analgesia
hernia repair

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

ClinicalTrials.gov processed this record on September 22, 2014