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CompletedNCT04719819CesARUpdated Feb 8, 2023

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

An observational study in Anesthesia, Spinal and Nonemergency Cesarean Section, sponsored by University Hospital, Clermont-Ferrand. Completed at 11 sites in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia, Spinal
  • Nonemergency Cesarean Section

Keywords

  • Anaesthesia, Spinal
  • Caesarean Section
  • Hyperbaric bupivacaine
  • Hemodynamic management after spinal anaesthesia
  • Maternal experience
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with spinal anaesthesia scheduled or non-emergency caesarean section

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (actual)
Patient registry
No

Groups and cohorts

  • Usual pratice

    Assessment of usual practices

    Procedure: Spinal anaesthesia for caesarean section

Interventions

  • ProcedureSpinal anaesthesia for caesarean section

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

06

What researchers measure

Primary outcomes

  1. Maternal data

    Ad hoc Questionnaire

    Time frame: Day of surgery

  2. Obstetrical data

    Ad hoc Questionnaire

    Time frame: Day of surgery

  3. Spinal procedure

    Ad hoc Questionnaire

    Time frame: Day of surgery

  4. Haemodynamic management

    Ad hoc Questionnaire

    Time frame: Day of surgery

  5. Maternal experience

    Ad hoc Questionnaire

    Time frame: Day of surgery

07

Study locations

11 sites
  • CHU
    Clermont-Ferrand, France
  • CHU
    Grenoble, France
  • Hôpital Emile Roux
    Le Puy-en-Velay, France
  • CHU
    Lille, France
  • HCL
    Lyon, France
  • CHU
    Nancy, France
  • CHU
    Nîmes, France
  • APHP Cochin
    Paris, France
  • APHP Necker
    Paris, France
  • APHP Trousseau
    Paris, France
  • Hôpital Jacques Puel
    Rodez, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04719819
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Jan 31, 2021
Primary completion
Dec 20, 2022
Completion
Feb 3, 2023
Last update
Feb 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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