Anesthesia, SpinalCesARNCT04719819
Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study
An observational study of Anesthesia, Spinal and Nonemergency Cesarean Section, run by University Hospital, Clermont-Ferrand at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal, Nonemergency Cesarean Section
- What is being tested?
- Spinal anaesthesia for caesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 11 sitesFrance
- Study dates
- 31 Jan 2021to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with spinal anaesthesia scheduled or non-emergency caesarean section
Who may be able to join
- Age ≥ 18 years old
- Affiliation to social security system
- Scheduled or elective Caesarean section (green code) under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU
Clermont-Ferrand
CHU
Grenoble
Hôpital Emile Roux
Le Puy-en-Velay
CHU
Lille
HCL
Lyon
CHU
Nancy
CHU
Nîmes
APHP Cochin
Paris
APHP Necker
Paris
APHP Trousseau
Paris
Hôpital Jacques Puel
Rodez
About this study
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.
- Conditions
- Anesthesia, Spinal, Nonemergency Cesarean Section
- Being tested
- Spinal anaesthesia for caesarean section
- Keywords
- Anaesthesia, Spinal, Caesarean Section, Hyperbaric bupivacaine, Hemodynamic management after spinal anaesthesia, Maternal experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesia for caesarean sectionProcedure or surgery
Descriptive questionnaire with open and closed questions, to be completed during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Usual pratice | Assessment of usual practices Receives: Procedure: Spinal anaesthesia for caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal data
Ad hoc Questionnaire
Measured: Day of surgery
Obstetrical data
Ad hoc Questionnaire
Measured: Day of surgery
Spinal procedure
Ad hoc Questionnaire
Measured: Day of surgery
Haemodynamic management
Ad hoc Questionnaire
Measured: Day of surgery
Maternal experience
Ad hoc Questionnaire
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start31 Jan 2021
- Primary completion20 Dec 2022
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719819
- Sponsor's protocol ID
- RNI 2020 BONNIN
- Acronym
- CesAR
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study
- ClinicalTrials.gov ID
- NCT04719819
- Acronym / sponsor ID
- CesAR / RNI 2020 BONNIN
- Conditions
- Anesthesia, Spinal, Nonemergency Cesarean Section
- Keywords
- Anaesthesia, Spinal, Caesarean Section, Hyperbaric bupivacaine, Hemodynamic management after spinal anaesthesia, Maternal experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual pratice | – | Procedure: Spinal anaesthesia for caesarean sectionAssessment of usual practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with spinal anaesthesia scheduled or non-emergency caesarean section
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Affiliation to social security system
- Scheduled or elective Caesarean section (green code) under spinal anesthesia
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anaesthesia for caesarean sectionDescriptive questionnaire with open and closed questions, to be completed during the procedure | Procedure or surgery | Usual pratice |
Primary outcome
Maternal data
Time frame: Day of surgery
Ad hoc Questionnaire
Obstetrical data
Time frame: Day of surgery
Ad hoc Questionnaire
Spinal procedure
Time frame: Day of surgery
Ad hoc Questionnaire
Haemodynamic management
Time frame: Day of surgery
Ad hoc Questionnaire
Maternal experience
Time frame: Day of surgery
Ad hoc Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Spinal and Nonemergency Cesarean Section, run by University Hospital, Clermont-Ferrand at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal data (time frame: Day of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.