Regional Anesthesia MorbidityRAMCESNCT05233462
Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia
A study testing standardized dose and adjusted dose in people with Regional Anesthesia Morbidity and Cesarean Section Complications, run by University Hospital, Caen at 1 site in France.
Trial summary
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication
- What is being tested?
- standardized dose and adjusted dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- scheduled cesarean section with intrathecal anesthesia
- term pregnancy > 35 weeks
- signed informed consent
Who cannot join
- unscheduled or emergent cesarean section
- any contra indication to intrathecal anesthesia
- any antihypertensive drug prescribed to control arterial pressure during pregnancy
- pre-eclampsia and eclampsia
- history of Marfan or Ehlers Danlos disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Jean Luc Hanouz, hanouz-jl@chu-caen.fr
About this study
Official title: Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section.
Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally.
To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.
Read the detailed description
The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section
- a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms
- a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms
The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure.
Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension
- Conditions
- Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication
- Being tested
- standardized dose, adjusted dose
- Keywords
- cesarean section, intrathecal anesthesia, bupivacaine, morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized doseOther
Also called standardized dose of bupivacaine
intrathecal anesthesia with 10 mg of bupivacaine
adjusted doseOther
Also called adjusted dose of bupivacaine
intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | intrathecal administration of a solution containing
* bupivacaine 10 mg
* morphine 100 micrograms
* sufentanil 3 micrograms Receives: Other: standardized dose |
| individualized group | Experimental | intrathecal administration of a solution containing
* bupivacaine 0.05 mg per cm of patient's height
* morphine 100 micrograms
* sufentanil 3 micrograms Receives: Other: adjusted dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of arterial hypotension
rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks
Measured: 4 hours since the start of intrathecal bupivacaine administration
Secondary outcomes (5)
vasopressor total dose
total dose of vasopressor administered during intrathecal anesthesia
Measured: 4 hours since the start of intrathecal bupivacaine administration
metameric level of intrathecal anesthesia
clinical evaluation of the metameric level obtained during intrathecal anesthesia
Measured: 4 hours since the start of intrathecal bupivacaine administration
lower limb motor block at the end of the caesarean section
lower limb motor block at the end of the caesarean section using Bromage score
Measured: 5 min after the end of caesarean section at newborn umbilical cord clamp
rate of need for general anesthesia
rate of need for general anesthesia because of intrathecal anesthesia failure or overdose
Measured: 5 min after the end of caesarean section at newborn umbilical cord clamp
patient's comfort self evaluation
patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable)
Measured: 4 hours since the start of intrathecal bupivacaine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start23 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled double blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-luc hanouz, Study chair, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233462
- Sponsor's protocol ID
- 21-0217
- Acronym
- RAMCES
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study
- ClinicalTrials.gov ID
- NCT05233462
- Acronym / sponsor ID
- RAMCES / 21-0217
- Conditions
- Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication
- Keywords
- cesarean section, intrathecal anesthesia, bupivacaine, morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2022 (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.
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section.
Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally.
To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.
Detailed description
The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section
- a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms
- a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms
The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure.
Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled double blind trial
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: standardized doseintrathecal administration of a solution containing * bupivacaine 10 mg * morphine 100 micrograms * sufentanil 3 micrograms |
| individualized group | Experimental | Other: adjusted doseintrathecal administration of a solution containing * bupivacaine 0.05 mg per cm of patient's height * morphine 100 micrograms * sufentanil 3 micrograms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- scheduled cesarean section with intrathecal anesthesia
- term pregnancy > 35 weeks
- signed informed consent
Key exclusion criteria (5 listed)
- unscheduled or emergent cesarean section
- any contra indication to intrathecal anesthesia
- any antihypertensive drug prescribed to control arterial pressure during pregnancy
- pre-eclampsia and eclampsia
- history of Marfan or Ehlers Danlos disease
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 |
|---|---|---|
| standardized doseAlso: standardized dose of bupivacaineintrathecal anesthesia with 10 mg of bupivacaine | Other | control group |
| adjusted doseAlso: adjusted dose of bupivacaineintrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height | Other | individualized group |
Primary outcome
rate of arterial hypotension
Time frame: 4 hours since the start of intrathecal bupivacaine administration
rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks
5 secondary outcomes
vasopressor total dose
Time frame: 4 hours since the start of intrathecal bupivacaine administration
metameric level of intrathecal anesthesia
Time frame: 4 hours since the start of intrathecal bupivacaine administration
lower limb motor block at the end of the caesarean section
Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp
rate of need for general anesthesia
Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp
patient's comfort self evaluation
Time frame: 4 hours since the start of intrathecal bupivacaine administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
jean-luc hanouz study chair
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized dose and adjusted dose in people with Regional Anesthesia Morbidity and Cesarean Section Complications, run by University Hospital, Caen at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jean-luc hanouz, M.D, Ph.D (02 31 06 47 36 ext. +33 1, hanouz-jl@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of arterial hypotension (time frame: 4 hours since the start of intrathecal bupivacaine administration). 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 25 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.