PRILOcaine for Cervical Cerclage trial (PRILOCC trial)

  • Research type

    Research Study

  • Full title

    Does subarachnoid administration of hyperbaric prilocaine produce an improved recovery from anaesthesia when compared with hyperbaric bupivacaine when used to make cervical cerclage easier in pregnant women at risk of pre-term loss?

  • IRAS ID

    225703

  • Contact name

    Neel Desai

  • Contact email

    Neel.Desai@gstt.nhs.uk

  • Sponsor organisation

    Guy's & St Thomas' Foundation NHS Trust R&D Department

  • Eudract number

    2019-001548-23

  • Duration of Study in the UK

    1 years, 11 months, 30 days

  • Research summary

    Cervical cerclage is a procedure that is carried out as a day case procedure in order to prevent preterm loss in at risk pregnancies. The anaesthetic used to facilitate this varies widely across the United Kingdom. Most centres use regional anaesthesia to avoid exposing the foetus to general anaesthetic drugs but it can be difficult to achieve discharge on the same day due to residual leg weakness and lack of bladder control. On occasions patients require urinary catheterization and admission to hospital.

    Prilocaine is a commonly used drug which has a shorter duration of action than bupivacaine which is the more commonly used drug for spinal anesthesia. Although prilocaine is used in the context of cervical cerclage, it is more expensive and there is no data to document that it has a significant advantage over bupivacaine.

    This study aims to compare the recovery profiles of equivalent doses of prilocaine and bupivacaine when administered by the intrathecal route to facilitate cervical cerclage. The main outcomes to be assessed will be time to return of leg movement, ability to pass urine, need for catheterization and discharge from hospital.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    20/LO/0231

  • Date of REC Opinion

    2 Apr 2020

  • REC opinion

    Favourable Opinion