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COMPLETED
NCT04394533
PHASE4

Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage?

Sponsor: Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

Summary

Patients that have a "cervical stitch" (cervical cerclage) require an anaesthetic. The most common choice is a spinal block. This is an injection in the back that makes the lower half of the body become temporarily numb and weak. The key aims when choosing which type of anaesthetic are safety for mother and baby, comfort during and after the procedure as well as patient convenience and satisfaction. There are two commonly available choices for the drug used in spinal anaesthesia, bupivacaine and prilocaine. Both have a long history of being safe and effective. One difference observed in studies of these drugs used for spinal anaesthetics in other surgeries is that prilocaine is shorter-acting and it, therefore, takes less time for the return of full strength and sensation of the lower body. This means patients are able to leave hospital sooner and are less likely to need a urinary catheter. The investigators want to see if these benefits can apply to patients having a cervical stitch too, by comparing the recovery of patients having a spinal anaesthetic with one of these two local anaesthetic medications.

Official 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?

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2021-08-27

Completion Date

2025-08-20

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DRUG

Prilocaine (Hyperbaric 2%)

2 ml hyperbaric prilocaine

DRUG

Bupivacaine (Hyperbaric 0.5%)

2 ml hyperbaric bupivacaine

Locations (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom