SEMPERFLO* Pain Management System in Inguinal Hernia Repair
NCT ID: NCT00423241
Last Updated: 2010-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2007-01-31
2008-01-31
Brief Summary
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\*Trademark
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SEMPERFLO Pain Management System
SEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
ON-Q PainBuster Post-Op Pain Relief System
ON-Q PainBuster Post-Op Pain Relief System
continuous infusion of 0.5% bupivacaine at 2mL per hour
Interventions
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SEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
ON-Q PainBuster Post-Op Pain Relief System
continuous infusion of 0.5% bupivacaine at 2mL per hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is 18 years or older
* Subject must be willing to participate in the study, and provide informed consent to participate.
Exclusion Criteria
* 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;
18 Years
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Ethicon Inc.
Principal Investigators
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Martin Weisberg, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Boca Raton Community Hospital
Boca Raton, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Washington University
St Louis, Missouri, United States
Universtiy of Tennessee
Knoxville, Tennessee, United States
North Texas Surgery Center
Dallas, Texas, United States
Michale E. DeBakey VA Medical Center
Houston, Texas, United States
Countries
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Other Identifiers
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200-06-004
Identifier Type: -
Identifier Source: org_study_id
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