Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Completed; Phase 2

Conditions: Pregnant Women

Treatments: Drug: HB Prilocaine 2%; Drug: HB Prilocaine 2% (varying dose); Drug: Morphine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03036384

NB076201627436

Details and patient eligibility

About

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,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 155 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: Sequential Assignment

Masking: Double Blind

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40 participants in 10 patient groups

Cohort 1 : HB prilocaine 2%, 45mg

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: Sufentanil

Drug: HB Prilocaine 2%

Cohort 2 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 3 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 4 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 5 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 6 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 7 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 8 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 9 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil

Cohort 10 : HB prilocaine 2%, (30-55mg)

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%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.

Treatment:

Drug: Morphine

Drug: HB Prilocaine 2% (varying dose)

Drug: Sufentanil