Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy

• Status: Completed
• Trial end date: 2011-06-20
• Target enrollment: 0
• Participant gender: Male

Summary

This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.

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

Details

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

Criteria

Inclusion Criteria:

1. Man ≥18 years

2. Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or laparoscopic umbilical herniorrhaphy to be performed according to standard surgical technique under general anesthesia.

3. Willing to use opioid rescue analgesia.

Exclusion Criteria:

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

2. Scheduled for bilateral inguinal herniorrhaphy.

3. Undergone a prior herniorrhaphy at the location scheduled for repair.

4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.