Clinical Trials Directory

Trials / Completed

CompletedNCT04719819

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Status
Completed
Phase
Study type
Observational
Enrollment
600 (actual)
Sponsor
University Hospital, Clermont-Ferrand · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, dose of hyperbaric bupivacaine used, combination with adjuvants, hemodynamic management, and impact of these measures on maternal experience are not uniform. This study aims to describe practices of spinal anaesthesia for caesarean section in France to improve practices, guide new studies and establish protocols.

Detailed description

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, techniques of spinal anaesthesia are varied. Dose of hyperbaric bupivacaine used may shifted, varying intensity of sensor block but also hemodynamic side effect. Likewise, use of adjuvant is frequent and differs between centres. Management of the maternal hemodynamic is also discussed. While it is recognized that intraoperatively vascular filling alone is not effective, use of vasopressors is not unequivocal. For example, recent studies support the use of norepinephrine. Finally, maternal experience is a hot topic. Although insufficient anaesthesia is rare, it is often overlooked. There are few recommendations on the intraoperative treatment of insufficient anaesthesia and to the management of post-traumatic stress that it lead to. The objective of this study is to describe practices of spinal anaesthesia for scheduled or non-emergency caesarean section (also named "green code") in France by detailing several points: Technique of spinal anaesthesia: * The anaesthesia solution used (doses and adjuvants) * Management of hemodynamic * Management of insufficient anaesthesia * Maternal experience It aims to make an inventory of practices, to orient future studies, guide practice and the realization of protocols. It is an observational study unfolds from 2021 to 2022. It concerns 11 French centres and 600 women. Data are collected with an online questionnaire.

Conditions

Interventions

TypeNameDescription
PROCEDURESpinal anaesthesia for caesarean sectionDescriptive questionnaire with open and closed questions, to be completed during the procedure

Timeline

Start date
2021-01-31
Primary completion
2022-12-20
Completion
2023-02-03
First posted
2021-01-22
Last updated
2023-02-08

Locations

11 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04719819. Inclusion in this directory is not an endorsement.