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
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
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.
Summary of Results
Prilocaine is a spinal anaesthetic commonly used for day surgery because it wears off relatively quickly. However, it is less commonly used for cervical cerclage, a procedure in which a stitch is placed around the cervix to help prevent premature birth. This study compared prilocaine with another spinal anaesthetic, bupivacaine, to find out whether women recovered more quickly after receiving prilocaine. The study recruited 135 pregnant women undergoing cervical cerclage at several hospitals. Women were randomly assigned to receive either prilocaine or bupivacaine, together with fentanyl for additional pain relief. Neither the women nor the researchers assessing their recovery knew which anaesthetic they had received. One woman was excluded because of missing information, leaving 67 women in each group. Women who received prilocaine regained full leg movement after an average of 88 minutes, compared with 129 minutes after bupivacaine. Their numbness also wore off approximately 55 minutes sooner, they passed urine 75 minutes sooner and they walked 59 minutes sooner. They met the criteria for going home approximately 90 minutes earlier. All these differences were statistically significant.
Both anaesthetics were similarly effective for the procedure, but prilocaine allowed women to recover movement and sensation more quickly and be ready to go home sooner.REC name
London - Central Research Ethics Committee
REC reference
20/LO/0231
Date of REC Opinion
2 Apr 2020
REC opinion
Favourable Opinion