Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Anesthesia, Spinal Clinical Trial

— CesAR  

Official title:

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719819
• Other study ID #: RNI 2020 BONNIN
• Status: Completed
• Start date: January 31, 2021
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 3, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Nonemergency Cesarean Section

Intervention

Procedure:
• Spinal anaesthesia for caesarean section
Descriptive questionnaire with open and closed questions, to be completed during the procedure

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal data	Ad hoc Questionnaire	Day of surgery
Primary	Obstetrical data	Ad hoc Questionnaire	Day of surgery
Primary	Spinal procedure	Ad hoc Questionnaire	Day of surgery
Primary	Haemodynamic management	Ad hoc Questionnaire	Day of surgery
Primary	Maternal experience	Ad hoc Questionnaire	Day of surgery