EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

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

Details

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

Criteria

Inclusion Criteria:

• Females, 18-75 years of age inclusive.

• American Society of Anesthesiologist (ASA) physical status 1-3.

• Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).

• Physically and mentally able to participate in the study and complete all study assessments.

• Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

• Demonstrated 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.

• 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.

• 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.