Clinical trial NCT04719819: Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study
Official title: Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Nonemergency Cesarean Section
Keywords: Anaesthesia, Spinal
Caesarean Section
Hyperbaric bupivacaine
Hemodynamic management after spinal anaesthesia
Maternal experience
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with spinal anaesthesia scheduled or non-emergency caesarean section

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal data
timeFrame: Day of surgery
measure: Obstetrical data
timeFrame: Day of surgery
measure: Spinal procedure
timeFrame: Day of surgery
measure: Haemodynamic management
timeFrame: Day of surgery
measure: Maternal experience
timeFrame: Day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU
city: Le Puy-en-Velay
country: France
facility: Hôpital Emile Roux
city: Lille
country: France
facility: CHU
city: Lyon
country: France
facility: HCL
city: Nancy
country: France
facility: CHU
city: Nîmes
country: France
facility: CHU
city: Paris
country: France
facility: APHP Cochin
city: Paris
country: France
facility: APHP Necker
city: Paris
country: France
facility: APHP Trousseau
city: Rodez
country: France
facility: Hôpital Jacques Puel
Study officials:
References: