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SEMPERFLO* Pain Management System in Inguinal Hernia Repair

NCT00423241 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2010-08-23

No results posted yet for this study

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

Conditions

  • Inguinal Hernia
  • Pain

Interventions

DEVICE

SEMPERFLO Pain Management System

continuous infusion of 0.5% bupivacaine at 2mL per hour

DEVICE

ON-Q PainBuster Post-Op Pain Relief System

continuous infusion of 0.5% bupivacaine at 2mL per hour

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Weisberg, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00423241 on ClinicalTrials.gov