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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

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