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Completed

NCT Number: NCT04719819

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anaesthesia for caesarean section

Procedure

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

Primary outcomes

  1. Maternal data

    Time frame: Day of surgery

    Ad hoc Questionnaire

  2. Obstetrical data

    Time frame: Day of surgery

    Ad hoc Questionnaire

  3. Spinal procedure

    Time frame: Day of surgery

    Ad hoc Questionnaire

  4. Haemodynamic management

    Time frame: Day of surgery

    Ad hoc Questionnaire

  5. Maternal experience

    Time frame: Day of surgery

    Ad hoc Questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: CesAR

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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