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

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ClinicalTrials.gov Identifier: NCT03036384
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Brief Summary:
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 prilocain 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)

Condition or disease Intervention/treatment Phase
Pregnant Women Drug: HB Prilocaine 2% (varying dose) Drug: HB Prilocaine 2% Drug: Sufentanil 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 ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)
Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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 paturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2%
The dose of 60mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 2 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 3 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 4 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 5 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 6 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 8 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 9 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine

Experimental: Cohort 10 : 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%, associated with sufentanyl, 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). Possible dose levels are 45, 50, 55, 60, 65, 70mg.
Drug: HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of 60mg of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 5µg of sufentanyl
Other Name: Tachipri

Drug: Sufentanil
5µg sufentanyl

Drug: Morphine
100 µgMorphine




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. 2. 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 30 minutes until total regression of sensory block (T12-S1).

  2. Side-effects (nausea, vomiting,prurit) [ 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 occurred after complete release of sensory block at the gluteal level, at the tighs and at the legs. At Day 0, Day 1, Day 3 and Day 5

  4. Pain as assessed by Visual Analog Scale [ Time Frame: up to 24 hours after surgery ]
    Pain levels will be determined at incision, baby delivery, peritoneal and skin closure, every 5 minutes during surgery, and thereafter every 4 hours for 24 hours. Visual Analog pain 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 surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). 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)



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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 foetale 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): NCT03036384


Locations
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Belgium
University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
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: NCT03036384     History of Changes
Other Study ID Numbers: NB076201627436
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: December 2016
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
Sufentanil
Prilocaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local