Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant (Césarcaïne)

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