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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Spinal; Nonemergency Cesarean Section
• Intervention / Treatment: Procedure: Spinal anaesthesia for caesarean section

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.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU
  • Grenoble, France
    • CHU
  • Le Puy-en-Velay, France
    • Hôpital Emile Roux
  • Lille, France
    • CHU
  • Lyon, France
    • HCL
  • Nancy, France
    • CHU
  • Nîmes, France
    • CHU
  • Paris, France
    • APHP Cochin
  • Paris, France
    • APHP Necker
  • Paris, France
    • APHP Trousseau
  • Rodez, France
    • Hôpital Jacques Puel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with spinal anaesthesia scheduled or non-emergency caesarean section

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Usual pratice; Assessment of usual practices	Procedure: Spinal anaesthesia for caesarean section; Descriptive questionnaire with open and closed questions, to be completed during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal data	Ad hoc Questionnaire	Day of surgery
Obstetrical data	Ad hoc Questionnaire	Day of surgery
Spinal procedure	Ad hoc Questionnaire	Day of surgery
Haemodynamic management	Ad hoc Questionnaire	Day of surgery
Maternal experience	Ad hoc Questionnaire	Day of surgery

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2021
• Primary Completion (ACTUAL): December 20, 2022
• Study Completion (ACTUAL): February 3, 2023

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Caesarean Section; Anaesthesia, Spinal; Hyperbaric bupivacaine; Hemodynamic management after spinal anaesthesia; Maternal experience
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: RNI 2020 BONNIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No