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TerminatedNCT00423241Updated Aug 23, 2010

SEMPERFLO* Pain Management System in Inguinal Hernia Repair

An interventional study of SEMPERFLO Pain Management System and ON-Q PainBuster Post-Op Pain Relief System in Inguinal Hernia and Pain, sponsored by Ethicon, Inc.. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-23.

Sponsored by Ethicon, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Market dynamics including other technologies made the project not viable.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

Read the detailed description

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

02

Conditions studied

  • Inguinal Hernia
  • Pain
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 7 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    SEMPERFLO Pain Management System

    Device: SEMPERFLO Pain Management System

  • Active comparator
    ON-Q PainBuster Post-Op Pain Relief System

    Device: ON-Q PainBuster Post-Op Pain Relief System

Interventions

  • DeviceSEMPERFLO Pain Management System

    continuous infusion of 0.5% bupivacaine at 2mL per hour

    Also known as: Pain management system

  • DeviceON-Q PainBuster Post-Op Pain Relief System

    continuous infusion of 0.5% bupivacaine at 2mL per hour

    Also known as: Pain management system

06

What researchers measure

Primary outcomes

  1. Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale

    Time frame: twenty-four hours post procedure

Secondary outcomes

  1. Narcotic and non-narcotic analgesic usage

    Time frame: 24, 48, 72, 96 and 120 hours post- procedure

  2. Numeric pain scale scores at rest and with coughing

    Time frame: 24, 48, 72, 96, and 120 hours post-procedure

07

Study locations

6 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00423241
Lead sponsor
Ethicon, Inc.
First posted
Jan 18, 2007
Start date
Jan 2007
Primary completion
Nov 2007
Completion
Jan 2008
Last update
Aug 23, 2010

Study contacts

Martin Weisberg, MD
study director · Ethicon, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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