NCT00626886

Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy

A Phase II, Randomized, Single Dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Innocoll · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.

Detailed description

Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges. 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 study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Conditions

• Postoperative Pain
• Inguinal Hernia

Interventions

Type	Name	Description
DRUG	Bupivacaine Collagen Sponge	collagen; Bupivacaine hydrocholoride
DRUG	placebo collagen sponge	collagen

Timeline

• Start date: 2008-03-11
• Primary completion: 2009-01-29
• Completion: 2009-01-29
• First posted: 2008-02-29
• Last updated: 2021-01-11
• Results posted: 2021-01-11

Locations

1 site across 1 country: United States