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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764283
First Posted: October 2, 2008
Last Update Posted: April 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Ghent
  Purpose
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.

Condition Intervention
Postoperative Pain Device: Tegaderm dressing Device: Epi-Fix dressing Device: Lockit-Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Epidural catheter migration from insertion till removal [ Time Frame: Until removal of the epidural catheter ]

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

Estimated Enrollment: 200
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764283


Locations
Belgium
AZ Maria Middelares Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Eric Mortier, MD, PhD University Ghent
  More Information

Responsible Party: Eric Mortier, University Ghent
ClinicalTrials.gov Identifier: NCT00764283     History of Changes
Other Study ID Numbers: 2008/278
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: April 15, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms