Hernia Repair Using Implant with Anesthetic – Phase III

The Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to Less Than 17 Years of Age Following Open Inguinal Hernia Repair

Protocol Description

This multi-center study evaluates an implant, called INL-001, that contains a numbing medicine embedded in collagen matrix designed for use in hernia surgery. The anesthetic used in the implant, bupivacaine, is approved as a local numbing medicine and is commonly used in pediatric hernia surgery. Researchers will be evaluating how well the implant controls pain after hernia surgery in the groin area compared to liquid bupivacaine administered conventionally.

Study Level: Phase III

Eligibility Criteria

Children ages 2 through 16 who have been scheduled for inguinal (groin) hernia surgery are eligible for participation.
Boys and Girls: Ages 2 to through 16


Participants will be randomly assigned to receive the INL-001 implant or be given standard of care, liquid bupivacaine hydrochloride placed into the incision to repair the hernia at the end of surgery. INL-001 turns into a soft gel-like substance once it comes in contact with body fluids and dissolves over time. This gel is absorbed by the body over time. During hospitalization, participants will have blood draws, assessments for pain and monitoring for side effects.
Visits: Requires hospitalization for surgery, and 2 follow up visits
Duration: 30 days following surgery

Status: Open for Enrollment

Source(s) of Support

Innocoll Pharmaceuticals

Primary Investigator

Mihaela Visoiu, MD

Contact Information

For more information about the study or enrollment, please contact: 
Denise McCarthy RN, BSN, CRC