Clinical trial NCT03433976: Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant
Official title: Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cesarean
Keywords: Caesarean section
spinal anesthesia
Prilocaïne
motor block
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hopital Saint Roch
First posted: 2018-02-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* Patient \<18 years
* Pathological pregnancy
* Multiple pregnancy
* Emergency caesarean
* Patients who cannot give informed consent (not French speaking)
* Refusal of the patient
* Contraindications to spinal anesthesia
* Contraindications to Prilocaine
* Contraindications to Bupivacaine

Primary outcomes:
measure: duration of motor block
timeFrame: up to 6 hours
Secondary outcomes:
measure: The upper sensory level
timeFrame: 15 minutes after the LA injection
measure: Hypotensive episodes
timeFrame: 1 day
measure: The time between injection and incision
timeFrame: 1 day
measure: The duration of the intervention
timeFrame: 1 day
measure: The time to return to the standard maternity ward
timeFrame: 1 day
measure: APGAR score of newborns at birth
timeFrame: 1 day
measure: The delay between spinal anesthesia and the first emergency analgesic injection
timeFrame: 1 day
measure: Assessment of pain (VAS)
timeFrame: 1 day
measure: The delay between spinal anesthesia and the first injection of second-line analgesia
timeFrame: 1 day
measure: The presence of neuro-sensory disorders within 24 hours postoperatively
timeFrame: 1 day
measure: The presence of post lumbar puncture syndrome
timeFrame: 1 day
measure: score de satisfaction
timeFrame: 1 day
measure: Statifaction of the Surgeon
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: christophe DADURE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.