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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

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.