NCT02131090

Brief Summary

A number of methods are currently used to prevent movement of epidural catheters in women during labour. These usually consist of sticky dressings applied to the patient's back. The purpose of this study is to compare how much epidural catheters move when secured with three commonly used different fixation dressings with the aim of identifying the best method of securing epidural catheters. Movement of epidural catheters has several clinical implications. Usually only a short length of epidural catheter is left in the epidural space, and therefore any significant movement could result in the catheter moving out of the epidural space leading to a loss of the pain relieving effects of the epidural. Once epidural failure has occurred due to catheter migration, a second catheter must be inserted in order to re-establish pain relief and thus the patient is exposed to the risks of epidural insertion for a second time. If the researchers in this study can identify a method of fixing epidural catheters which results in the least amount of catheter movement, then patients could benefit from more reliable epidural pain relief, fewer repeated procedures and the risks associated with repeated procedures. The principle objective of the study is to determine which epidural fixation dressing results in the least amount of epidural catheter movement from the time of epidural insertion (during labour) to the time of epidural removal (after labour).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

March 31, 2014

Last Update Submit

November 25, 2014

Conditions

LabourChildbirth

Keywords

EpiduralCatheterFixationDeviceIntrapartum

Outcome Measures

Primary Outcomes (1)

  • Migration of epidural catheter in centimetres

    Upon epidural removal within 1 hour from delivery

Secondary Outcomes (4)

  • Comfort of each fixation device for women during labour.

    Upon epidural removal within 1 hour from delivery

  • Structural integrity of each dressing.

    Upon epidural removal within 1 hour from delivery

  • Rate of epidural failures associated with each fixation device.

    Upon epidural removal within 1 hour from delivery

  • Effect of Body Mass Index on dressing integrity

    Upon epidural removal within 1 hour from delivery

Study Arms (3)

Tegaderm TM

EXPERIMENTAL

Participants in this arm of the study will receive the Tegaderm dressing to secure the epidural catheter

Device: Tegaderm TM

Lock-it Plus

EXPERIMENTAL

Participants in this arm of the study will receive the Lock-it Plus dressing to secure the epidural catheter

Device: Lock-it Plus

Epifix

EXPERIMENTAL

Participants in this arm of the study will receive the Epifix dressing to secure the epidural catheter

Device: Epifix

Interventions

Tegaderm TMDEVICE

This is a generic adhesive dressing which is commonly used to secure epidural catheters.

Tegaderm TM
Lock-it PlusDEVICE

This dressing is specifically designed for securing epidural catheters. It is adhesive to the patient's back and has a plastic clamp through which the epidural catheter passes. Once closed, the clamp secures the catheter.

Also known as: Manufactured by Smith's Medical
Lock-it Plus
EpifixDEVICE

This dressing is specifically designed to secure epidural catheters. It is adhesive to the patient's back and has a foam, moulded mechanism through which the catheter is passed. An adhesive flap folds over the whole mechanism to secure the catheter.

Also known as: Epifix is manufactured by Unomedical
Epifix

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>18
  • Patient in labour, requesting an epidural.
  • Primi-parous women
  • Multi-parous women
  • BMI \< 50

You may not qualify if:

  • BMI \>50
  • Documented diagnosis of scoliosis and/or other significant lumbar spinal pathology
  • Previous lumbar spinal surgery
  • Any contraindication to epidural analgesia
  • Admitted for termination of pregnancy or intra-uterine death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Georges Hospital NHS Trust

London, Tooting, sw17 0QT, United Kingdom

Location

Study Officials

  • Peter Odor

    St George's, University of London

    STUDY CHAIR

  • sohail Bampoe

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

May 6, 2014

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

GB(1)