The Prevention of Postoperative Epidural Catheter Migrati... | NCT00764283

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

NCT00764283

Sponsor

University Ghent

Status

Completed

Last Update Posted

Apr 15, 2009Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Tegaderm dressing
Epi-Fix dressing
Lockit-Plus

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Oct 1, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2009

Last Update Posted Date

Apr 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tegaderm dressing	Device	Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epidural catheter migration from insertion till removal		Until removal of the epidural catheter

Secondary Outcomes

Measure	Description	Time Frame
Problems of analgesia during Patient Controlled Epidural Analgesia		Until removal of the epidural catheter
Body Mass Index		Until removal of the epidural catheter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Mortier, MD, PhD	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Maria Middelares Ghent		Ghent		9000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided