SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Stopped early · Not applicable

Conditions studied: Inguinal Hernia, Pain

In brief

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

Key facts

Study ID

NCT00423241

Run by

Ethicon, Inc.

People needed

7

Starts

2007-01-01

Expected to finish

2008-01-01

Last updated by the study team

2010-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Boca Raton Community Hospital — Boca Raton, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Washington University — St Louis, Missouri, United States
• Universtiy of Tennessee — Knoxville, Tennessee, United States
• North Texas Surgery Center — Dallas, Texas, United States
• Michale E. DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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