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

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ClinicalTrials.gov Identifier: NCT03607916
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

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)

Condition or disease Intervention/treatment Phase
Pregnant Women Drug: Hyperbaric prilocaine 2% Drug: Morphine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery : a Dose-finding Study Based on the Continual Reassessment.
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Cohort 1 : HB Prilocaine 2%,(60mg)
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%
The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 2 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 3 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 4 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 5 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 6 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 7 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 8 : HB Prilocaïne 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 9 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine

Experimental: Cohort 10 : HB Prilocaine 2%,(45-70mg)
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%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
Other Name: Tachipri

Drug: Morphine
100µg morphine




Primary Outcome Measures :
  1. Success of anesthesia [ Time Frame: during surgery (average 1 hour) ]
    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


Secondary Outcome Measures :
  1. Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure [ Time Frame: Until complete release of sensory block (T12-S1) (average 4 hours) ]
    Every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once every hour until total regression of sensory block (T12-S1).

  2. Side-effects (nausea, vomiting,pruritus) [ Time Frame: up to 24 hours after surgery ]
    from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated)

  3. Transient neurologic symptoms (TNS) [ Time Frame: up to 5 Days ]
    TNS are defined as pain and/or dysesthesia occured after complete release of sensory block at the gluteal level, at the tights and at the legs. At Day 0, Day 1, day 3 and Day 5

  4. Pain as assessed by Visual Analogue Scale (VAS) [ Time Frame: during surgery (average 1 hour) ]
    Pain levels will be determined every 5 minutes during surgery. The Visual Analogue score (scale : 0 = no pain; 10= worst pain imaginable)

  5. Number of participants with low blood pressure [ Time Frame: during surgery (average 1 hour) ]
    Arterial blood pressure will be measured at every 2.5 minute during the first 15 minutes, then at every 5 minutes until the end of surgery. A blood pressure lower is define as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)

  6. Methemoglobinemia [ Time Frame: at delivery (average 1 hour) ]
    Methemoglobin level measured in umbilical cord blood of new born at the delivery



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607916


Locations
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Belgium
University Hospital Saint-Pierre, Université Libre de Bruxelles
Brussels Capital Region, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Study Director: Panayota KAPESSIDOU, MD, PhD University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Principal Investigator: Philippe Goffard, MD University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Publications:
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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03607916    
Other Study ID Numbers: B076201524085
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Scheduled cesarean delivery,spinal anesthesia,local anesthesia
Additional relevant MeSH terms:
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Morphine
Prilocaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics