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Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study (CesAR)

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Nonemergency Cesarean Section
Anesthesia, Spinal

Treatments

Procedure: Spinal anaesthesia for caesarean section

Study type

Observational

Funder types

Other

Identifiers

NCT04719819
RNI 2020 BONNIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Usual pratice
Description:
Assessment of usual practices
Treatment:
Procedure: Spinal anaesthesia for caesarean section

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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