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

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

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

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.

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.