Childbirth Clinical Trial
Official title:
A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial
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.
1. Women admitted to labour ward at St. George's Hospital will be invited to participate
in the study. Written informed consent will be obtained from all potential
participants.
2. Women in labour who request an epidural will be randomly allocated to one of three
different dressings used to secure the epidural. The epidural will be performed by the
duty anaesthetist according to a standard practice. The three epidural dressings are:
3M Tegaderm, Smiths Medical Lockit Plus and Unomedical Epifix. All dressing will be
applied in a standardised manner. Since 3M Tegaderm is the current dressing used at St.
George's Hospital it will form the control group.
3. Epidurals will be inserted by the duty anaesthetist using a standard technique and the
appropriate dressing applied. In order to avoid bias women will not be informed which
device they are to receive.
4. Patient characteristics will be documented for each epidural, including length of
catheter at skin at time of insertion, depth to epidural space, intervertebral
interspace used (e.g. L3-4), patient position for epidural insertion (lateral or
sitting), time and date of epidural insertion, patient body mass index (at booking). No
identifying patient data will be recorded.
5. If an epidural is removed before delivery or the epidural fixation device is altered
then the reason for intervention will be documented e.g. inadequacy of epidural
analgesia, loss of integrity of fixation device. Any specific events that precipitate
problems with the epidural fixation devices will be documented e.g. discomfort at site
of dressing on transfer of patient onto operating theatre table.
6. After delivery of the baby, the epidural catheter will be removed. Removal will be
encouraged within the first hour following delivery and before the patient has
mobilised from their bed. If possible then the woman will adopt the same position
(either sitting or lateral) for removal of the epidural as she was in for insertion.
Removal of the catheter will either be by a midwife or the duty anaesthetist.
7. After removal of the epidural the following patient characteristics will be collected
by the midwife or anaesthetist removing the catheter: length of catheter at skin at
time of removal, patient position for epidural removal (lateral or sitting), time and
date of epidural removal, integrity of epidural dressing, whether the patient was
transferred to the operating theatre table, any additional problems encountered with
the epidural or dressing.
8. No specific restrictions will be placed on participants following epidural insertion,
other than those that are routine for all labouring women with epidurals. However any
women who move off their bed and walk before removal of their epidural catheter will be
excluded from the study, since walking may cause the epidural catheter to migrate more
than it would do so usually during labour.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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