SEMPERFLO* Pain Management System in Inguinal Hernia Repair

NCT ID: NCT00423241

Last Updated: 2010-08-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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

Conditions

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Inguinal Hernia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SEMPERFLO Pain Management System

Group Type EXPERIMENTAL

SEMPERFLO Pain Management System

Intervention Type DEVICE

continuous infusion of 0.5% bupivacaine at 2mL per hour

ON-Q PainBuster Post-Op Pain Relief System

Group Type ACTIVE_COMPARATOR

ON-Q PainBuster Post-Op Pain Relief System

Intervention Type DEVICE

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

Intervention Type DEVICE

ON-Q PainBuster Post-Op Pain Relief System

continuous infusion of 0.5% bupivacaine at 2mL per hour

Intervention Type DEVICE

Other Intervention Names

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Pain management system Pain management system

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role lead

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

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Universtiy of Tennessee

Knoxville, Tennessee, United States

Site Status

North Texas Surgery Center

Dallas, Texas, United States

Site Status

Michale E. DeBakey VA Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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200-06-004

Identifier Type: -

Identifier Source: org_study_id

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