Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00764283
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
University Ghent

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date April 15, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Epidural catheter migration from insertion till removal [ Time Frame: Until removal of the epidural catheter ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00764283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Official Title  ICMJE The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Device: Tegaderm dressing
    Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
  • Device: Epi-Fix dressing
    Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
  • Device: Lockit-Plus
    Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia
Study Arms  ICMJE
  • Experimental: 1
    Tegaderm dressing
    Intervention: Device: Tegaderm dressing
  • Active Comparator: 2
    Epi-Fix dressing
    Intervention: Device: Epi-Fix dressing
  • Active Comparator: 3
    Lockit-Plus dressing
    Intervention: Device: Lockit-Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764283
Other Study ID Numbers  ICMJE 2008/278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Mortier, University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Mortier, MD, PhD University Ghent
PRS Account University Ghent
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP