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Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04719819
Acronym
CesAR
Enrollment
600
Registered
2021-01-22
Start date
2021-01-31
Completion date
2023-02-03
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Nonemergency Cesarean Section

Keywords

Anaesthesia, Spinal, Caesarean Section, Hyperbaric bupivacaine, Hemodynamic management after spinal anaesthesia, Maternal experience

Brief 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.

Interventions

PROCEDURESpinal anaesthesia for caesarean section

Descriptive questionnaire with open and closed questions, to be completed during the procedure

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 18 years old * Affiliation to social security system * Scheduled or elective Caesarean section (green code) under spinal anesthesia

Exclusion criteria

* Refusal to participate in the study * Code red Caesarean section or general anesthesia decision * Complicated Caesarean section or combined spinal-epidural technique * Presence of an epidural catheter * Performing a combined spinal-epidural technique (even if the epidural catheter is not used) * Contraindication to spinal anaesthesia (coagulation disorder, vertebral-medullary pathologies) * Patient under guardianship or curatorship

Design outcomes

Primary

MeasureTime frameDescription
Maternal dataDay of surgeryAd hoc Questionnaire
Obstetrical dataDay of surgeryAd hoc Questionnaire
Spinal procedureDay of surgeryAd hoc Questionnaire
Haemodynamic managementDay of surgeryAd hoc Questionnaire
Maternal experienceDay of surgeryAd hoc Questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026