A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial
Condition: Labour; Childbirth
Study type: Interventional

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).
    

Detailed description: 
      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.
    

Intervention name(s): Tegaderm TM; Lock-it Plus; Epifix
Intervention type(s): Device; Device; Device
Intervention description(s): This is a generic adhesive dressing which is commonly used to secure epidural catheters.; 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.; 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.
Other intervention name(s): Manufactured by Smith's Medical; Epifix is manufactured by Unomedical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Epidural; Catheter; Fixation; Device; Intrapartum