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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

January 16, 2007
August 20, 2010
January 2007
November 2007   (final data collection date for primary outcome measure)
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 ]
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale at twenty-four hours post procedure.
Complete list of historical versions of study NCT00423241 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Narcotic and non-narcotic analgesic usage at 24, 48, 72, 96 and 120 hours post- procedure.
  • Numeric pain scale scores at rest and with coughing at 24, 48, 72, 96, and 120 hours post-procedure.
Not Provided
Not Provided
 
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

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Inguinal Hernia
  • Pain
  • Device: SEMPERFLO Pain Management System
    continuous infusion of 0.5% bupivacaine at 2mL per hour
    Other Name: Pain management 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
  • Experimental: SEMPERFLO Pain Management System
    Intervention: Device: SEMPERFLO Pain Management System
  • Active Comparator: ON-Q PainBuster Post-Op Pain Relief System
    Intervention: Device: ON-Q PainBuster Post-Op Pain Relief System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2008
November 2007   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00423241
200-06-004
No
Jonathan Batiller, MBA, Ethicon Inc.
Ethicon, Inc.
Not Provided
Study Director: Martin Weisberg, MD Ethicon, Inc.
Ethicon, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP