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SEMPERFLO* Pain Management System in Inguinal Hernia Repair

This study has been terminated.
(Market dynamics including other technologies made the project not viable.)
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00423241
First received: January 16, 2007
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention
Inguinal Hernia
Pain
 Device: SEMPERFLO Pain Management System
Device: ON-Q PainBuster Post-Op Pain Relief System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cough Hernia
U.S. FDA Resources

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale [ Time Frame: twenty-four hours post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Narcotic and non-narcotic analgesic usage [ Time Frame: 24, 48, 72, 96 and 120 hours post- procedure ] [ Designated as safety issue: No ]
  • Numeric pain scale scores at rest and with coughing [ Time Frame: 24, 48, 72, 96, and 120 hours post-procedure ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEMPERFLO Pain Management System Device: SEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
Other Name: Pain management system
Active Comparator: ON-Q PainBuster Post-Op Pain Relief System Device: ON-Q PainBuster Post-Op Pain Relief System
continuous infusion of 0.5% bupivacaine at 2mL per hour
Other Name: Pain management system

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423241

Locations
United States, Florida
Boca Raton Community Hospital
Boca Raton, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States
United States, Tennessee
Universtiy of Tennessee
Knoxville, Tennessee, United States
United States, Texas
North Texas Surgery Center
Dallas, Texas, United States
Michale E. DeBakey VA Medical Center
Houston, Texas, United States
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Martin Weisberg, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Jonathan Batiller, MBA, Ethicon Inc.
ClinicalTrials.gov Identifier: NCT00423241     History of Changes
Other Study ID Numbers: 200-06-004
Study First Received: January 16, 2007
Last Updated: August 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 16, 2013