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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).
The null hypothesis is that there is no difference in epidural catheter migration between any of the epidural catheter fixation devices.
The study design has been chosen so that the researchers can fairly assess how different commercially available epidural fixation devices perform in the real life scenario of labour, a time when epidurals are particularly important to the well-being of a labouring woman. Three different epidural fixation methods will be studied. These three methods have been chosen because they are all already in use in different hospitals across the UK but have never been compared together.
Data will be analysed to determine whether the null hypothesis is accepted or rejected. Information about the study and any conclusion drawn will be published locally and nationally in order to inform decision making regarding which epidural catheter fixation device is best suited to reduce epidural migration in labouring women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegaderm TM | Experimental | Participants in this arm of the study will receive the Tegaderm dressing to secure the epidural catheter |
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| Lock-it Plus | Experimental | Participants in this arm of the study will receive the Lock-it Plus dressing to secure the epidural catheter |
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| Epifix | Experimental | Participants in this arm of the study will receive the Epifix dressing to secure the epidural catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaderm TM | Device | This is a generic adhesive dressing which is commonly used to secure epidural catheters. |
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| Measure | Description | Time Frame |
|---|---|---|
| Migration of epidural catheter in centimetres | Upon epidural removal within 1 hour from delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort of each fixation device for women during labour. | A simple questionnaire incorporated into the data collection sheet, section 3. Women will be asked whether the dressing was comfortable and their response will be recorded as either 'comfortable' or 'uncomfortable' | Upon epidural removal within 1 hour from delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Odor | St George's, University of London | Study Chair |
| sohail Bampoe | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Georges Hospital NHS Trust | London | Tooting | sw17 0QT | United Kingdom |
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| Lock-it Plus | Device | 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. |
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| Epifix | Device | 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. |
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| Structural integrity of each dressing. |
This will be assessed using a simple questionnaire as part of the data collection form in section 2. The midwife removing the epidural will record whether the dressing is either 'intact', 'partially peeled off' or 'completely peeled off'. |
| Upon epidural removal within 1 hour from delivery |
| Rate of epidural failures associated with each fixation device. | Assessed using the data collection questionnaire section 3. Data collectors will answer two questions: Has the epidural block partially failed? Yes or No. Partial failure is defined as pain despite epidural top ups, but not requiring the epidural to be re-sited. Has the epidural block completely failed? Yes or no. An epidural is defined as 'completely failed' if it needs to be re-sited at any point during labour. | Upon epidural removal within 1 hour from delivery |
| Effect of Body Mass Index on dressing integrity | The Body Mass Index (BMI) of each participant will be recorded. This data will be correlated with each dressing type and data collected regarding device integrity as collected in the data collection form section 2 as previously described. | Upon epidural removal within 1 hour from delivery |