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

Innocoll

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Hernia

Treatments: Drug: 5x5cm bupivacaine collagen sponges

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224145

INN-CB-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Drug: Bupivacaine Collagen Sponge

Experimental group

Description:

bupivacaine collagen sponges

Treatment:

Drug: 5x5cm bupivacaine collagen sponges