The PIEB Study

  • Research type

    Research Study

  • Full title

    The effects of different volumes and time intervals of a programmed intermittent epidural bolus (PIEB) regimen on patient-controlled epidural analgesia (PCEA) usage: a randomised double blind trial

  • IRAS ID

    173749

  • Contact name

    ROSHAN FERNANDO

  • Contact email

    roshan.fernando@uclh.nhs.uk

  • Sponsor organisation

    UCL Sponsor Rep

  • Clinicaltrials.gov Identifier

    R&D reference number, 15/0043

  • Duration of Study in the UK

    1 years, 6 months, 2 days

  • Research summary

    Epidurals remain the most effective form of pain relief for labour. An epidural is a small plastic tube which is inserted into a space in the back through which local anaesthetic is delivered. The local anaesthetic will numb the nerves to the abdomen and pelvis, thereby relieving pain associated with labour. There are many ways of delivering epidural local anaesthetic for labour pain relief. The newest method involves use of a specialised epidural pump (CADD®- Solis, Smith Medical) which ensures that a dose of local anaesthetic is delivered within a speicific time frame (e.g. every hour). This is called a programmed intermittent epidural bolus (PIEB). Furthermore, these pumps will also allow the patient to administer supplemental doses to themselves by pressing a button. This is called patient controlled epidural analgesia (PCEA). Early research into labour pain relief using the combination of PIEB and PCEA has shown that this specialised method of epidural delivery is superior to traditional methods of epidural drug delivery. It has been shown to reduce the total amount of local anaesthetic needed, reduce leg weakness, and improve patient satisfaction. The aim of this study is to evaluate which combined PIEB and PCEA regimen is best for labouring women.
    Once a labour epidural is inserted, we will start one of eight different PIEB/PCEA regimens which will be allocated randomly. The patient nor the anaesthetist looking after the woman would be aware of the regimen they have been allocated. We will continue to monitor the patients closely throughout their labour and after delivery and collect all necessary information.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    15/LO/1265

  • Date of REC Opinion

    27 Oct 2015

  • REC opinion

    Further Information Favourable Opinion