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

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00764283
First received: October 1, 2008
Last updated: April 14, 2009
Last verified: April 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Problems of analgesia during Patient Controlled Epidural Analgesia [ Time Frame: Until removal of the epidural catheter ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: Until removal of the epidural catheter ] [ Designated as safety issue: No ]
  • The integrity of the dressing [ Time Frame: Until removal of the epidural catheter ] [ Designated as safety issue: No ]
  • The comfort of the dressing [ Time Frame: Until removal of the epidural catheter ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eric Mortier, University Ghent
ClinicalTrials.gov Identifier: NCT00764283     History of Changes
Other Study ID Numbers: 2008/278
Study First Received: October 1, 2008
Last Updated: April 14, 2009
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014