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Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

NCT00472134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-06-08

No results posted yet for this study

Summary

The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are:

* reducing postoperative pain from this procedure
* decreasing length of hospital stay
* reducing or eliminating amount of post-operative narcotics used

Conditions

  • Hernia, Ventral

Interventions

DRUG

bupivacaine

administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.

DEVICE

On-Q PainBuster pump

local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Michael J. Rosen, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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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 NCT00472134 on ClinicalTrials.gov