Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant (Césarcaïne)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Unknown
Phase 2

Conditions

Cesarean

Treatments

Drug: spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT03433976
UF9859

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Hyperbaric Bupivacaine
Other group
Description:
spinal anesthesia for planned cesarean sections control group
Treatment:
Drug: spinal anesthesia
Hyperbaric Prilocaïne
Active Comparator group
Description:
spinal anesthesia for planned cesarean sections
Treatment:
Drug: spinal anesthesia

Trial contacts and locations

1

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Central trial contact

christophe DADURE, MD, PhD

Data sourced from clinicaltrials.gov

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