Status:
COMPLETED
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Hernia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01801124
Start Date
April 1 2012
End Date
December 1 2012
Last Update
March 8 2021
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219