SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Not Applicable

Terminated

• Conditions: Inguinal Hernia; Pain
• Interventions: Device: ON-Q PainBuster Post-Op Pain Relief System; Device: SEMPERFLO Pain Management System

• Registration Number: NCT00423241
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Primary Completion: 2007-11
• Study Completion: 2008-01
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-20
• Last Update Posted: 2010-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ON-Q PainBuster Post-Op Pain Relief System	ON-Q PainBuster Post-Op Pain Relief System	-
SEMPERFLO Pain Management System	SEMPERFLO Pain Management System	-

Primary Outcome Measures

Name	Time	Method
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale	twenty-four hours post procedure

Secondary Outcome Measures

Name	Time	Method
Numeric pain scale scores at rest and with coughing	24, 48, 72, 96, and 120 hours post-procedure
Narcotic and non-narcotic analgesic usage	24, 48, 72, 96 and 120 hours post- procedure

Trial Locations

Locations (6)

Boca Raton Community Hospital; 🇺🇸 Boca Raton, Florida, United States

Universtiy of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

North Texas Surgery Center; 🇺🇸 Dallas, Texas, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Michale E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States