SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Ethicon

Status

Terminated

Conditions

Inguinal Hernia

Pain

Treatments

Device: ON-Q PainBuster Post-Op Pain Relief System

Device: SEMPERFLO Pain Management System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00423241

200-06-004

Details and patient eligibility

About

This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures.

*Trademark

Full description

Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
Subject is 18 years or older
Subject must be willing to participate in the study, and provide informed consent to participate.

Exclusion criteria

Subjects undergoing recurrent hernia repair;
Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
Subjects with known allergy to bupivacaine;
Subjects with immunodeficiency diseases (including known HIV);
Subjects with any findings identified by the surgeon that may preclude conduct of the study;
Subjects who are known current alcohol and/or drug abusers;