SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Official Title: “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”

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

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SEMPERFLO Pain Management System
• Active Comparator: ON-Q PainBuster Post-Op Pain Relief System

Primary Measures

• Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
  • Time Frame: twenty-four hours post procedure
    Safety Issue?: No

Secondary Measures

• Narcotic and non-narcotic analgesic usage
  • Time Frame: 24, 48, 72, 96 and 120 hours post- procedure
    Safety Issue?: No
• Numeric pain scale scores at rest and with coughing
  • Time Frame: 24, 48, 72, 96, and 120 hours post-procedure
    Safety Issue?: No

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;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ethicon, Inc. Industry

Overall Clinical Trial Officials and Contacts

Martin Weisberg, MD Study Director Ethicon, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00423241

Study ID Number: 200-06-004

ClinicalTrials.gov Identifier: NCT00423241

Health Authority: United States: Institutional Review Board