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Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage?

NCT04394533 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • Cervical Incompetence in Pregnancy as Antepartum Condition

Interventions

DRUG

Prilocaine (Hyperbaric 2%)

2 ml hyperbaric prilocaine

DRUG

Bupivacaine (Hyperbaric 0.5%)

2 ml hyperbaric bupivacaine

Sponsors & Collaborators

  • Obstetric Anaesthetists' Association United Kingdom

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Desire Onwochei, MBBS · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394533 on ClinicalTrials.gov