Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

NCT ID: NCT04719819

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2023-02-03

Brief Summary

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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

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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.

Conditions

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Anesthesia, Spinal Nonemergency Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Usual pratice

Assessment of usual practices

Spinal anaesthesia for caesarean section

Intervention Type PROCEDURE

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

Interventions

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Spinal anaesthesia for caesarean section

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Clermont-Ferrand, , France

Site Status

CHU

Grenoble, , France

Site Status

Hôpital Emile Roux

Le Puy-en-Velay, , France

Site Status

CHU

Lille, , France

Site Status

HCL

Lyon, , France

Site Status

CHU

Nancy, , France

Site Status

CHU

Nîmes, , France

Site Status

APHP Cochin

Paris, , France

Site Status

APHP Necker

Paris, , France

Site Status

APHP Trousseau

Paris, , France

Site Status

Hôpital Jacques Puel

Rodez, , France

Site Status

Countries

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France

Other Identifiers

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RNI 2020 BONNIN

Identifier Type: -

Identifier Source: org_study_id

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