SEMPERFLO* Pain Management System in Inguinal Hernia Repair

August 20, 2010 updated by: Ethicon, Inc.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SEMPERFLO Pain Management System
Device: SEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
Other Names:
  • 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 Names:
  • Pain management system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Time Frame: twenty-four hours post procedure
twenty-four hours post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Narcotic and non-narcotic analgesic usage
Time Frame: 24, 48, 72, 96 and 120 hours post- procedure
24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing
Time Frame: 24, 48, 72, 96, and 120 hours post-procedure
24, 48, 72, 96, and 120 hours post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (ESTIMATE)

January 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2010

Last Update Submitted That Met QC Criteria

August 20, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200-06-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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