CesareanPhase 2CésarcaïneNCT03433976
Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant
A Phase 2 study testing spinal anesthesia in people with Cesarean, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean
- What is being tested?
- spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2018to 30 Aug 2020
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal pregnancy
- Scheduled caesarean section
- Non-multiple pregnancy
- Age of patient: 18 years and over
- Height of patient: between 155 and 175 cm
- Affiliated patients or beneficiaries of a Social Security System
- Signature of the patient's consent
Who cannot join
- Patient <18 years
- Pathological pregnancy
- Multiple pregnancy
- Emergency caesarean
- Patients who cannot give informed consent (not French speaking)
- Refusal of the patient
Show all 9Show fewer
- Contraindications to spinal anesthesia
- Contraindications to Prilocaine
- Contraindications to Bupivacaine
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Christophe DADURE, MD, phD, 467333856 ext. 33, c-dadure@chu-montpellier.fr
About this study
Official title: Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine
The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.
Read the detailed description
Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).
The number of subjects required is 50 patients, 25 per group.
- Conditions
- Cesarean
- Being tested
- spinal anesthesia
- Keywords
- Caesarean section, spinal anesthesia, Prilocaïne, motor block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaDrug
spinal anesthesia for planned cesarean sections
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Bupivacaine | Other | spinal anesthesia for planned cesarean sections control group Receives: Drug: spinal anesthesia |
| Hyperbaric Prilocaïne | Active comparator | spinal anesthesia for planned cesarean sections Receives: Drug: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of motor block
To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4
Measured: up to 6 hours
Secondary outcomes (13)
The upper sensory level
The upper sensory level obtained 15 minutes after the LA injection
Measured: 15 minutes after the LA injection
Hypotensive episodes
Hypotensive episodes
Measured: 1 day
The time between injection and incision
The time between injection and incision
Measured: 1 day
The duration of the intervention
The duration of the intervention
Measured: 1 day
The time to return to the standard maternity ward
The time to return to the standard maternity ward
Measured: 1 day
APGAR score of newborns at birth
APGAR score of newborns at birth. L'APGAR Apgar score is a method to quickly summarize the health of newborn children.
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).
The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Measured: 1 day
The delay between spinal anesthesia and the first emergency analgesic injection
The delay between spinal anesthesia and the first emergency analgesic injection
Measured: 1 day
Assessment of pain (VAS)
Pain on arrival and departure of PACU and at 24 hours. Pain will be assessedby VAS (Visual Analogue Scale); Patients rate pain on VAS from 0-10, 0 being no pain and 10 being the worst pain imaginable..
Measured: 1 day
The delay between spinal anesthesia and the first injection of second-line analgesia
The delay between spinal anesthesia and the first injection of second-line analgesia : delay between spinal anesthesia ans the need of rescue analgesia
Measured: 1 day
The presence of neuro-sensory disorders within 24 hours postoperatively
The presence of neuro-sensory disorders within 24 hours postoperatively
Measured: 1 day
The presence of post lumbar puncture syndrome
The presence of post lumbar puncture syndrome
Measured: 1 day
score de satisfaction
Patient satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Patients rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction
Measured: 1 day
Statifaction of the Surgeon
The surgeon assessed his satisfaction while the cesarien section. The surgeon satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Surgeon rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start7 May 2018
- Primary completion7 May 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CesareanStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Saint Roch
- Responsible party
- Sponsor
- Investigators
- christophe DADURE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433976
- Sponsor's protocol ID
- UF9859
- Acronym
- Césarcaïne
- Status last verified
- Mar 2018
- First submitted
- 21 Dec 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Chapron K, Sleth JC, Capdevila X, Bringuier S, Dadure C. Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study. Anaesthesia. 2021 Jun;76(6):777-784. doi: 10.1111/anae.15342. Epub 2021 Jan 11.
PubMed 33428221
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine
- ClinicalTrials.gov ID
- NCT03433976
- Acronym / sponsor ID
- Césarcaïne / UF9859
- Conditions
- Cesarean
- Keywords
- Caesarean section, spinal anesthesia, Prilocaïne, motor block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hopital Saint Roch
- Study start
- 7 May 2018 (actual)
- Primary completion
- 7 May 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 15 Feb 2018 (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.
The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.
Detailed description
Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).
The number of subjects required is 50 patients, 25 per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Bupivacaine | Other | Drug: spinal anesthesiaspinal anesthesia for planned cesarean sections control group |
| Hyperbaric Prilocaïne | Active comparator | Drug: spinal anesthesiaspinal anesthesia for planned cesarean sections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal pregnancy
- Scheduled caesarean section
- Non-multiple pregnancy
- Age of patient: 18 years and over
- Height of patient: between 155 and 175 cm
Key exclusion criteria (9 listed)
- Patient <18 years
- Pathological pregnancy
- Multiple pregnancy
- Emergency caesarean
- Patients who cannot give informed consent (not French speaking)
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 anesthesiaspinal anesthesia for planned cesarean sections | Drug | Hyperbaric Bupivacaine, Hyperbaric Prilocaïne |
Primary outcome
duration of motor block
Time frame: up to 6 hours
To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4
13 secondary outcomes
The upper sensory level
Time frame: 15 minutes after the LA injection
Hypotensive episodes
Time frame: 1 day
The time between injection and incision
Time frame: 1 day
The duration of the intervention
Time frame: 1 day
The time to return to the standard maternity ward
Time frame: 1 day
APGAR score of newborns at birth
Time frame: 1 day
The delay between spinal anesthesia and the first emergency analgesic injection
Time frame: 1 day
Assessment of pain (VAS)
Time frame: 1 day
The delay between spinal anesthesia and the first injection of second-line analgesia
Time frame: 1 day
The presence of neuro-sensory disorders within 24 hours postoperatively
Time frame: 1 day
The presence of post lumbar puncture syndrome
Time frame: 1 day
score de satisfaction
Time frame: 1 day
Statifaction of the Surgeon
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 33428221Chapron K, Sleth JC, Capdevila X, Bringuier S, Dadure C. Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study. Anaesthesia. 2021 Jun;76(6):777-784. doi: 10.1111/anae.15342. Epub 2021 Jan 11.
- Individual participant dataSharing planned: Undecided. NC
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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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.
christophe DADURE principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing spinal anesthesia in people with Cesarean, run by University Hospital, Montpellier 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact christophe DADURE, MD, PhD (467338256 ext. 33, c-dadure@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of motor block (time frame: up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433976, which also lists 1 linked publication.
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 11 Dec 2018.