NCT00423241

SEMPERFLO* Pain Management System in Inguinal Hernia Repair

A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia
• Pain

Interventions

Type	Name	Description
DEVICE	SEMPERFLO Pain Management System	continuous infusion of 0.5% bupivacaine at 2mL per hour
DEVICE	ON-Q PainBuster Post-Op Pain Relief System	continuous infusion of 0.5% bupivacaine at 2mL per hour

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2008-01-01
• First posted: 2007-01-18
• Last updated: 2010-08-23

Locations

6 sites across 1 country: United States