NCT00764283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

October 1, 2008

Last Update Submit

April 14, 2009

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Epidural catheter migration from insertion till removal

    Until removal of the epidural catheter

Secondary Outcomes (4)

  • Problems of analgesia during Patient Controlled Epidural Analgesia

    Until removal of the epidural catheter

  • Body Mass Index

    Until removal of the epidural catheter

  • The integrity of the dressing

    Until removal of the epidural catheter

  • The comfort of the dressing

    Until removal of the epidural catheter

Study Arms (3)

1

EXPERIMENTAL

Tegaderm dressing

Device: Tegaderm dressing

2

ACTIVE COMPARATOR

Epi-Fix dressing

Device: Epi-Fix dressing

3

ACTIVE COMPARATOR

Lockit-Plus dressing

Device: Lockit-Plus

Interventions

Tegaderm dressingDEVICE

Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia

1
Epi-Fix dressingDEVICE

Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia

2
Lockit-PlusDEVICE

Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
  • years or older

You may not qualify if:

  • Patients who did not sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Eric Mortier, MD, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

BE(1)