The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing

April 14, 2009 updated by: University Ghent
Three types of dressing will be compared to prevent postoperative epidural catheter migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length of the epidural catheter visible at the patient's skin surface will be recorded after insertion and every day until removal. The integrity of the dressing and problems with analgesia will also be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Az Maria Middelares Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
  • 18 years or older

Exclusion Criteria:

  • Patients who did not sign an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Tegaderm dressing
Device: Tegaderm dressing
Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
Active Comparator: 2
Epi-Fix dressing
Device: Epi-Fix dressing
Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
Active Comparator: 3
Lockit-Plus dressing
Device: Lockit-Plus
Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epidural catheter migration from insertion till removal
Time Frame: Until removal of the epidural catheter
Until removal of the epidural catheter

Secondary Outcome Measures

Outcome Measure
Time Frame
Problems of analgesia during Patient Controlled Epidural Analgesia
Time Frame: Until removal of the epidural catheter
Until removal of the epidural catheter
Body Mass Index
Time Frame: Until removal of the epidural catheter
Until removal of the epidural catheter
The integrity of the dressing
Time Frame: Until removal of the epidural catheter
Until removal of the epidural catheter
The comfort of the dressing
Time Frame: Until removal of the epidural catheter
Until removal of the epidural catheter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Eric Mortier, MD, PhD, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2009

Last Update Submitted That Met QC Criteria

April 14, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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