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

NCT03607916 | Completed Phase 2

• 1 other identifier: B076201524085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Pregnant Women

Keywords

Scheduled cesarean delivery,spinal anesthesia,local anesthesia

Outcome Measures

Primary Outcomes (1)

• Success of anesthesia

  The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision

  during surgery (average 1 hour)

Secondary Outcomes (6)

• Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure

  Until complete release of sensory block (T12-S1) (average 4 hours)

• Side-effects (nausea, vomiting,pruritus)

  up to 24 hours after surgery

• Transient neurologic symptoms (TNS)

  up to 5 Days

• Pain as assessed by Visual Analogue Scale (VAS)

  during surgery (average 1 hour)

• Number of participants with low blood pressure

  during surgery (average 1 hour)

Study Arms (10)

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

Cohort 8 : HB Prilocaïne 2%,(45-70mg)

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

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

EXPERIMENTAL

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.

Drug: Hyperbaric prilocaine 2%; Drug: Morphine

Interventions

Hyperbaric prilocaine 2% DRUG

Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine

Also known as: Tachipri

Cohort 10 : HB Prilocaine 2%,(45-70mg); Cohort 2 : HB Prilocaine 2%,(45-70mg); Cohort 3 : HB Prilocaine 2%,(45-70mg); Cohort 4 : HB Prilocaine 2%,(45-70mg); Cohort 5 : HB Prilocaine 2%,(45-70mg); Cohort 6 : HB Prilocaine 2%,(45-70mg); Cohort 7 : HB Prilocaine 2%,(45-70mg); Cohort 8 : HB Prilocaïne 2%,(45-70mg); Cohort 9 : HB Prilocaine 2%,(45-70mg)

Morphine DRUG

100µg morphine

Cohort 1 : HB Prilocaine 2%,(60mg); Cohort 10 : HB Prilocaine 2%,(45-70mg); Cohort 2 : HB Prilocaine 2%,(45-70mg); Cohort 3 : HB Prilocaine 2%,(45-70mg); Cohort 4 : HB Prilocaine 2%,(45-70mg); Cohort 5 : HB Prilocaine 2%,(45-70mg); Cohort 6 : HB Prilocaine 2%,(45-70mg); Cohort 7 : HB Prilocaine 2%,(45-70mg); Cohort 8 : HB Prilocaïne 2%,(45-70mg); Cohort 9 : HB Prilocaine 2%,(45-70mg)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

University Hospital Saint-Pierre, Université Libre de Bruxelles

Brussels Capital Region, 1000, Belgium

Location

Related Publications (2)

• Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.

  PMID: 20529983 BACKGROUND

• Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7.

  PMID: 23393153 BACKGROUND

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Panayota KAPESSIDOU, MD, PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• Philippe Goffard, MD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)