Back to resultsThe Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tegaderm dressing
Epi-Fix dressing
Lockit-Plus
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility 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
Sites / Locations
- AZ Maria Middelares Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Tegaderm dressing
Epi-Fix dressing
Lockit-Plus dressing
Outcomes
Primary Outcome Measures
Epidural catheter migration from insertion till removal
Secondary Outcome Measures
Problems of analgesia during Patient Controlled Epidural Analgesia
Body Mass Index
The integrity of the dressing
The comfort of the dressing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00764283
Brief Title
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Official Title
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Tegaderm dressing
Arm Title
2
Arm Type
Active Comparator
Arm Description
Epi-Fix dressing
Arm Title
3
Arm Type
Active Comparator
Arm Description
Lockit-Plus dressing
Intervention Type
Device
Intervention Name(s)
Tegaderm dressing
Intervention Description
Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
Intervention Type
Device
Intervention Name(s)
Epi-Fix dressing
Intervention Description
Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
Intervention Type
Device
Intervention Name(s)
Lockit-Plus
Intervention Description
Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia
Primary Outcome Measure Information:
Title
Epidural catheter migration from insertion till removal
Time Frame
Until removal of the epidural catheter
Secondary Outcome Measure Information:
Title
Problems of analgesia during Patient Controlled Epidural Analgesia
Time Frame
Until removal of the epidural catheter
Title
Body Mass Index
Time Frame
Until removal of the epidural catheter
Title
The integrity of the dressing
Time Frame
Until removal of the epidural catheter
Title
The comfort of the dressing
Time Frame
Until removal of the epidural catheter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Mortier, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
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The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
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