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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764283
• Other study ID #: 2008/278
• Status: Completed
• Phase: N/A
• First received: October 1, 2008
• Last updated: April 14, 2009
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Tegaderm dressing
Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
• Epi-Fix dressing
Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
• Lockit-Plus
Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural catheter migration from insertion till removal		Until removal of the epidural catheter	No
Secondary	Problems of analgesia during Patient Controlled Epidural Analgesia		Until removal of the epidural catheter	No
Secondary	Body Mass Index		Until removal of the epidural catheter	No
Secondary	The integrity of the dressing		Until removal of the epidural catheter	No
Secondary	The comfort of the dressing		Until removal of the epidural catheter	No