Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Completed; Phase 2

Conditions: Pregnant Women

Treatments: Drug: Morphine; Drug: Hyperbaric prilocaine 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT03607916

B076201524085

Details and patient eligibility

About

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists physical status (ASA) < III
• Age 18-40 year
• Body Weight <100 kg
• Height between 160 and 175 cm
• Gestational age>37 SA
• Elective cesarean delivery
• Singleton pregnancy
• Non complicated pregnancy
• Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion criteria

• Twin pregnancy
• History of 2 cesarean section or more
• Diabetes and gestational diabetes
• Placenta praevia
• Congenital foetal abnormality
• Patient in labour
• Membrane rupture
• Known allergy to local anaesthetics
• Disagreement of the patient
• Pregnancy-induced hypertension
• Pre eclampsia and eclampsia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 10 patient groups

Cohort 1 : HB Prilocaine 2%,(60mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 2 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 3 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 4 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 5 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 6 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 7 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 paturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be adminitrated at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 8 : HB Prilocaïne 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 9 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%

Cohort 10 : HB Prilocaine 2%,(45-70mg)

Experimental group

Description:

Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.

Treatment:

Drug: Hyperbaric prilocaine 2%

Drug: Morphine

Drug: Hyperbaric prilocaine 2%