SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00423241
• Other study ID #: 200-06-004
• Status: Terminated
• Phase: N/A
• First received: January 16, 2007
• Last updated: August 20, 2010
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2010
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain

Intervention

Device:
• SEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
• ON-Q PainBuster Post-Op Pain Relief System
continuous infusion of 0.5% bupivacaine at 2mL per hour

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale		twenty-four hours post procedure	No
Secondary	Narcotic and non-narcotic analgesic usage		24, 48, 72, 96 and 120 hours post- procedure	No
Secondary	Numeric pain scale scores at rest and with coughing		24, 48, 72, 96, and 120 hours post-procedure	No