Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

• Status: Completed
• Trial end date: 2011-05-18
• Target enrollment: 0
• Participant gender: Male

Summary

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborator: Premier Research Group plc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Man ≥ 18 years

• Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.

• Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.

Exclusion Criteria:

• Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.

• Scheduled for bilateral inguinal herniorrhaphy.

• Undergone a prior herniorrhaphy on the side scheduled for repair.

• Undergone major surgery within 3 mos of the scheduled herniorrhaphy.

• Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.

• Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).

• Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.