Comparing two anaesthetics for cervical cerclage procedures
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?
This study is testing which of two anaesthetics, prilocaine or bupivacaine, helps pregnant women recover faster and feel more comfortable during cervical cerclage procedures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04394533 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness and recovery profiles of hyperbaric prilocaine and hyperbaric bupivacaine as anaesthetics for cervical cerclage procedures in pregnant women. The aim is to determine which anaesthetic allows for quicker recovery and discharge while ensuring safety and comfort for both mother and baby. Participants will receive either prilocaine or bupivacaine during the procedure, and their recovery will be monitored to assess the differences in motor and sensory block regression. The study focuses on healthy pregnant women undergoing elective cervical cerclage under spinal anaesthesia.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women over 18 years old, presenting for elective cervical cerclage.
Not a fit: Patients with serious co-morbidities, contraindications to spinal anaesthesia, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anaesthetic options for cervical cerclage, enhancing recovery times and patient satisfaction.
How similar studies have performed: Previous studies have shown varying success with similar anaesthetic comparisons, but this specific approach in the context of cervical cerclage is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB. * Age \> 18 years Exclusion Criteria: * Inability to read or understand the patient information sheet (PIS) * Age \< 18 years * Unable or unwilling to consent to participation * non-elective procedure * serious co-morbidities (ASA score 4 or above) * any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication * any history of allergic reaction to any of the medications in the protocol * concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics) * any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.
Where this trial is running
London
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Desire Onwochei, MBBS — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Desire Onwochei, MBBS
- Email: desire.onwochei@gstt.nhs.uk
- Phone: 02071880644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.