Back to resultsSEMPERFLO* Pain Management System in Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia, Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEMPERFLO Pain Management System
ON-Q PainBuster Post-Op Pain Relief System
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility 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;
Sites / Locations
- Boca Raton Community Hospital
- Jacksonville Center for Clinical Research
- Washington University
- Universtiy of Tennessee
- North Texas Surgery Center
- Michale E. DeBakey VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SEMPERFLO Pain Management System
ON-Q PainBuster Post-Op Pain Relief System
Arm Description
Outcomes
Primary Outcome Measures
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Secondary Outcome Measures
Narcotic and non-narcotic analgesic usage
Numeric pain scale scores at rest and with coughing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00423241
Brief Title
SEMPERFLO* Pain Management System in Inguinal Hernia Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
Market dynamics including other technologies made the project not viable.
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEMPERFLO Pain Management System
Arm Type
Experimental
Arm Title
ON-Q PainBuster Post-Op Pain Relief System
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SEMPERFLO Pain Management System
Other Intervention Name(s)
Pain management system
Intervention Description
continuous infusion of 0.5% bupivacaine at 2mL per hour
Intervention Type
Device
Intervention Name(s)
ON-Q PainBuster Post-Op Pain Relief System
Other Intervention Name(s)
Pain management system
Intervention Description
continuous infusion of 0.5% bupivacaine at 2mL per hour
Primary Outcome Measure Information:
Title
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Time Frame
twenty-four hours post procedure
Secondary Outcome Measure Information:
Title
Narcotic and non-narcotic analgesic usage
Time Frame
24, 48, 72, 96 and 120 hours post- procedure
Title
Numeric pain scale scores at rest and with coughing
Time Frame
24, 48, 72, 96, and 120 hours post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Weisberg, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Universtiy of Tennessee
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
North Texas Surgery Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Michale E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SEMPERFLO* Pain Management System in Inguinal Hernia Repair
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