NCT01224145

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

A Phase II, Single-dose, Open-label Study to Investigate the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Laparoscopic Inguinal or Umbilical Herniorrhaphy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Innocoll · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. This open-label study will assess pain intensity after surgery in patients who receive the CollaRx Bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.

Conditions

• Hernia
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	5x5cm bupivacaine collagen sponges

Timeline

• Start date: 2011-03-22
• Primary completion: 2011-06-20
• Completion: 2011-06-20
• First posted: 2010-10-19
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

1 site across 1 country: United States