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

NCT ID: NCT00764283

Last Updated: 2009-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Tegaderm dressing

Group Type EXPERIMENTAL

Tegaderm dressing

Intervention Type DEVICE

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

2

Epi-Fix dressing

Group Type ACTIVE_COMPARATOR

Epi-Fix dressing

Intervention Type DEVICE

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

3

Lockit-Plus dressing

Group Type ACTIVE_COMPARATOR

Lockit-Plus

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tegaderm dressing

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

Intervention Type DEVICE

Epi-Fix dressing

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

Intervention Type DEVICE

Lockit-Plus

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Ghent

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric Mortier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AZ Maria Middelares Ghent

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008/278

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.