Study Stopped
Market dynamics including other technologies made the project not viable.
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
1 other identifier
interventional
7
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedAugust 23, 2010
August 1, 2010
10 months
January 16, 2007
August 20, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
twenty-four hours post procedure
Secondary Outcomes (2)
Narcotic and non-narcotic analgesic usage
24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing
24, 48, 72, 96, and 120 hours post-procedure
Study Arms (2)
SEMPERFLO Pain Management System
EXPERIMENTALON-Q PainBuster Post-Op Pain Relief System
ACTIVE COMPARATORInterventions
continuous infusion of 0.5% bupivacaine at 2mL per hour
continuous infusion of 0.5% bupivacaine at 2mL per hour
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethicon, Inc.lead
Study Sites (6)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Weisberg, MD
Ethicon, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 1, 2007
Primary Completion
November 1, 2007
Study Completion
January 1, 2008
Last Updated
August 23, 2010
Record last verified: 2010-08