Postoperative PainNCT00764283
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
A study testing Tegaderm dressing, Epi-Fix dressing and Lockit-Plus in people with Postoperative Pain, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Tegaderm dressing, Epi-Fix dressing and Lockit-Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
- 18 years or older
Who cannot join
- Patients who did not sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Tegaderm dressing, Epi-Fix dressing, Lockit-Plus
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm dressingDevice
Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
Epi-Fix dressingDevice
Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
Lockit-PlusDevice
Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tegaderm dressing Receives: Device: Tegaderm dressing |
| 2 | Active comparator | Epi-Fix dressing Receives: Device: Epi-Fix dressing |
| 3 | Active comparator | Lockit-Plus dressing Receives: Device: Lockit-Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural catheter migration from insertion till removal
Measured: Until removal of the epidural catheter
Secondary outcomes (4)
Problems of analgesia during Patient Controlled Epidural Analgesia
Measured: Until removal of the epidural catheter
Body Mass Index
Measured: Until removal of the epidural catheter
The integrity of the dressing
Measured: Until removal of the epidural catheter
The comfort of the dressing
Measured: Until removal of the epidural catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Eric Mortier, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764283
- Sponsor's protocol ID
- 2008/278
- Status last verified
- Apr 2009
- First submitted
- 1 Oct 2008
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
- ClinicalTrials.gov ID
- NCT00764283
- Acronym / sponsor ID
- 2008/278
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Tegaderm dressingTegaderm dressing |
| 2 | Active comparator | Device: Epi-Fix dressingEpi-Fix dressing |
| 3 | Active comparator | Device: Lockit-PlusLockit-Plus dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
- 18 years or older
Key exclusion criteria (1 listed)
- Patients who did not sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegaderm dressingTegaderm dressing is used to secure the epidural catheter for postoperative analgesia | Device | 1 |
| Epi-Fix dressingEpi-Fix dressing is used to secure the epidural catheter for postoperative analgesia | Device | 2 |
| Lockit-PlusLockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia | Device | 3 |
Primary outcome
Epidural catheter migration from insertion till removal
Time frame: Until removal of the epidural catheter
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Mortier, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm dressing, Epi-Fix dressing and Lockit-Plus in people with Postoperative Pain, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural catheter migration from insertion till removal (time frame: Until removal of the epidural catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2009.