Conditions: Hernioplasty
Keywords: unilateral inguinal hernioplasty
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.

Detailed description:
Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh hernioplasty 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 Xaracoll 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 surgical site to provide postoperative pain control.

This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

Arms:
arm 1: Bupivacaine HCl implant arm 2: Bupivacaine HCl implant arm 3: Bupivacaine HCl

Interventions: intervention 1: 2 100mg Xaracoll implants intervention 2: 3 100mg Xaracoll implants intervention 3: 150mg Bupivacaine HCl injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: