<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036384</url>
  </required_header>
  <id_info>
    <org_study_id>NB076201627436</org_study_id>
    <nct_id>NCT03036384</nct_id>
  </id_info>
  <brief_title>Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly&#xD;
      used for spinal injection in cesarean section. Nevertheless, its use often results in a long&#xD;
      duration of motor nerve block and a haemodynamical instability. Recently developped, the&#xD;
      Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for&#xD;
      hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for&#xD;
      intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the&#xD;
      effect of the local anesthetics while decreasing their dose-related side effects, the aim of&#xD;
      this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled&#xD;
      cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of Anesthesia</measure>
    <time_frame>during surgery (average 1 hour)</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitive Block Duration</measure>
    <time_frame>Until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
    <description>Level of Sensory block assessed as loss of sensation to cold, 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitive Block at End of Surgery</measure>
    <time_frame>Until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
    <description>Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Block Duration</measure>
    <time_frame>Until complete release of motor block (Bromage scale = 1; average 4 hours)</time_frame>
    <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bromage Motor Block Level at End of Surgery</measure>
    <time_frame>Until complete release of motor block (average 4 hours)</time_frame>
    <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn Apgar Score</measure>
    <time_frame>up to 10 minutes after baby extraction</time_frame>
    <description>Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).&#xD;
The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn Methemoglobinemia (MetHb)</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Needing Vasopressors</measure>
    <time_frame>during surgery (average 1 hour)</time_frame>
    <description>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). Vasopressors were given for patients with low blood pressure.&#xD;
A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Transient Neurologic Symptoms (TNS)</measure>
    <time_frame>up to 5 Days</time_frame>
    <description>TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Nausea or Vomiting</measure>
    <time_frame>up to 24 hours after surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pruritus</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Urinary Retention</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>All parturients will be questioned for urinary retention (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dizziness</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>All parturients will be questioned for dizziness (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Satisfied Participants</measure>
    <time_frame>up to 1 hour after surgery</time_frame>
    <description>Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pregnant Women</condition>
  <arm_group>
    <arm_group_label>Cohort 1 : HB prilocaine 2%, 45mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 8 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 9 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 10 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HB Prilocaine 2% (varying dose)</intervention_name>
    <description>Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl</description>
    <arm_group_label>Cohort 10 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 2 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 3 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 4 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 5 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 6 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 7 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 8 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 9 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <other_name>Tachipri</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HB Prilocaine 2%</intervention_name>
    <description>The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl</description>
    <arm_group_label>Cohort 1 : HB prilocaine 2%, 45mg</arm_group_label>
    <other_name>Tachipri</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>2.5µg sufentanyl</description>
    <arm_group_label>Cohort 1 : HB prilocaine 2%, 45mg</arm_group_label>
    <arm_group_label>Cohort 10 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 2 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 3 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 4 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 5 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 6 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 7 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 8 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 9 : HB prilocaine 2%, (30-55mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>100 µg Morphine</description>
    <arm_group_label>Cohort 1 : HB prilocaine 2%, 45mg</arm_group_label>
    <arm_group_label>Cohort 10 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 2 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 3 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 4 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 5 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 6 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 7 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 8 : HB prilocaine 2%, (30-55mg)</arm_group_label>
    <arm_group_label>Cohort 9 : HB prilocaine 2%, (30-55mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status (ASA) &lt; III&#xD;
&#xD;
          -  Age 18-40 year&#xD;
&#xD;
          -  Body Weight &lt;100 kg&#xD;
&#xD;
          -  Height between 155 and 175 cm&#xD;
&#xD;
          -  Gestational age&gt;37 SA&#xD;
&#xD;
          -  Elective cesarean delivery&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Non complicated pregnancy&#xD;
&#xD;
          -  Signed informed consent obtained prior to any study specific assessments and&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Twin pregnancy&#xD;
&#xD;
          -  History of 2 cesarean section or more&#xD;
&#xD;
          -  Diabetes and gestational diabetes&#xD;
&#xD;
          -  Placenta praevia&#xD;
&#xD;
          -  Congenital foetal abnormality&#xD;
&#xD;
          -  Patient in labour&#xD;
&#xD;
          -  Membrane rupture&#xD;
&#xD;
          -  Known allergy to local anaesthetics&#xD;
&#xD;
          -  Disagreement of the patient&#xD;
&#xD;
          -  Pregnancy-induced hypertension&#xD;
&#xD;
          -  Pre eclampsia and eclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Panayota Kapessidou, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe Goffard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)</name>
      <address>
        <city>Brussels Capital Region</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20529983</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23393153</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>March 20, 2020</results_first_submitted>
  <results_first_submitted_qc>April 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2020</results_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>scheduled cesarean delivery</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>local anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were recruited at CHU Saint-Pierre.</recruitment_details>
      <pre_assignment_details>Possible doses of HB prilocaine range from 30 to 55mg, but actual administrated doses will be defined by CRM</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>45mg HB prilocaine initial dose; 4 patients</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>40mg HB prilocaine following CRM results; 4 patients</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3</title>
          <description>40mg HB prilocaine following CRM results; 4 patients</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4</title>
          <description>35mg HB prilocaine following CRM results; 4 patients</description>
        </group>
        <group group_id="P5">
          <title>Cohort 5</title>
          <description>50mg HB prilocaine following CRM results, 4 patients</description>
        </group>
        <group group_id="P6">
          <title>Cohort 6</title>
          <description>45mg HB prilocaine following CRM results, 4 patients</description>
        </group>
        <group group_id="P7">
          <title>Cohort 7</title>
          <description>45mg HB prilocaine following CRM results, 4 patients</description>
        </group>
        <group group_id="P8">
          <title>Cohort 8</title>
          <description>45mg HB prilocaine following CRM results, 4 patients</description>
        </group>
        <group group_id="P9">
          <title>Cohort 9</title>
          <description>40mg HB prilocaine following CRM results, 4 patients</description>
        </group>
        <group group_id="P10">
          <title>Cohort 10</title>
          <description>45mg HB prilocaine following CRM results, 4 patients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Statistical analysis (Mean +/- SD) was realized for the total number of patients for each dose proposed by CRM.</population>
      <group_list>
        <group group_id="B1">
          <title>35mg HB Prilocaine</title>
        </group>
        <group group_id="B2">
          <title>40mg HB Prilocaine</title>
        </group>
        <group group_id="B3">
          <title>45mg HB Prilocaine</title>
        </group>
        <group group_id="B4">
          <title>50mg HB Prilocaine</title>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" spread="8.76"/>
                    <measurement group_id="B2" value="35.08" spread="5.11"/>
                    <measurement group_id="B3" value="32.85" spread="4.93"/>
                    <measurement group_id="B4" value="29.85" spread="5.94"/>
                    <measurement group_id="B5" value="32.75" spread="5.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.5" spread="4.93"/>
                    <measurement group_id="B2" value="164.42" spread="4.45"/>
                    <measurement group_id="B3" value="162.8" spread="6.26"/>
                    <measurement group_id="B4" value="157" spread="6.16"/>
                    <measurement group_id="B5" value="162.38" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73" spread="16.02"/>
                    <measurement group_id="B2" value="82.17" spread="11.93"/>
                    <measurement group_id="B3" value="79.78" spread="11.6"/>
                    <measurement group_id="B4" value="84.68" spread="2.88"/>
                    <measurement group_id="B5" value="80.31" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravity</title>
          <units>number of pregnancies</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" spread="1.41"/>
                    <measurement group_id="B2" value="2.17" spread="1.03"/>
                    <measurement group_id="B3" value="3.1" spread="1.98"/>
                    <measurement group_id="B4" value="2" spread="0.96"/>
                    <measurement group_id="B5" value="2.70" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>number of deliveries</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.25" spread="0.5"/>
                    <measurement group_id="B2" value="0.67" spread="0.49"/>
                    <measurement group_id="B3" value="1.3" spread="1.98"/>
                    <measurement group_id="B4" value="0.75" spread="0.96"/>
                    <measurement group_id="B5" value="1.05" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous Caesarean Section (CS)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>no previous caeserean</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 previous caeserean</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Term</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.5" spread="0.58"/>
                    <measurement group_id="B2" value="38.42" spread="1.08"/>
                    <measurement group_id="B3" value="38.40" spread="0.94"/>
                    <measurement group_id="B4" value="38.75" spread="1.26"/>
                    <measurement group_id="B5" value="38.45" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Success of Anesthesia</title>
        <description>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</description>
        <time_frame>during surgery (average 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>45mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>40mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>40mg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>35mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>50mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>45mg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>45mg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 8</title>
            <description>45mg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 9</title>
            <description>40mg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 10</title>
            <description>45mg</description>
          </group>
        </group_list>
        <measure>
          <title>Success of Anesthesia</title>
          <description>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</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitive Block Duration</title>
        <description>Level of Sensory block assessed as loss of sensation to cold, 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).</description>
        <time_frame>Until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Sensitive Block Duration</title>
          <description>Level of Sensory block assessed as loss of sensation to cold, 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).</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.31" spread="0.48"/>
                    <measurement group_id="O2" value="3.25" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitive Block at End of Surgery</title>
        <description>Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)</description>
        <time_frame>Until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Sensitive Block at End of Surgery</title>
          <description>Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Dermatome level</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" spread="1.59"/>
                    <measurement group_id="O2" value="3.00" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motor Block Duration</title>
        <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.</description>
        <time_frame>Until complete release of motor block (Bromage scale = 1; average 4 hours)</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Motor Block Duration</title>
          <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="0.45"/>
                    <measurement group_id="O2" value="3.50" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bromage Motor Block Level at End of Surgery</title>
        <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.</description>
        <time_frame>Until complete release of motor block (average 4 hours)</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Bromage Motor Block Level at End of Surgery</title>
          <description>Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="0.51"/>
                    <measurement group_id="O2" value="4.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Newborn Apgar Score</title>
        <description>Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).&#xD;
The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).</description>
        <time_frame>up to 10 minutes after baby extraction</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Newborn Apgar Score</title>
          <description>Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).&#xD;
The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Apgar at 1 minute</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.47" spread="1.84"/>
                    <measurement group_id="O2" value="9.00" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apgar at 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.63" spread="0.96"/>
                    <measurement group_id="O2" value="9.75" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apgar at 10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.84" spread="0.50"/>
                    <measurement group_id="O2" value="10" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Newborn Methemoglobinemia (MetHb)</title>
        <description>Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.</description>
        <time_frame>average 1 hour</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Newborn Methemoglobinemia (MetHb)</title>
          <description>Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>percentage of MetHb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.59" spread="0.53"/>
                    <measurement group_id="O2" value="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Needing Vasopressors</title>
        <description>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). Vasopressors were given for patients with low blood pressure.&#xD;
A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia).</description>
        <time_frame>during surgery (average 1 hour)</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Needing Vasopressors</title>
          <description>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). Vasopressors were given for patients with low blood pressure.&#xD;
A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia).</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Transient Neurologic Symptoms (TNS)</title>
        <description>TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5</description>
        <time_frame>up to 5 Days</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Transient Neurologic Symptoms (TNS)</title>
          <description>TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Nausea or Vomiting</title>
        <description>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)</description>
        <time_frame>up to 24 hours after surgery</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Nausea or Vomiting</title>
          <description>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)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pruritus</title>
        <description>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)</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pruritus</title>
          <description>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)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Urinary Retention</title>
        <description>All parturients will be questioned for urinary retention (yes or no)</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Urinary Retention</title>
          <description>All parturients will be questioned for urinary retention (yes or no)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dizziness</title>
        <description>All parturients will be questioned for dizziness (yes or no)</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dizziness</title>
          <description>All parturients will be questioned for dizziness (yes or no)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Satisfied Participants</title>
        <description>Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)</description>
        <time_frame>up to 1 hour after surgery</time_frame>
        <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
        <group_list>
          <group group_id="O1">
            <title>45mg HB Prilocaine</title>
          </group>
          <group group_id="O2">
            <title>50mg HB Prilocaine</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Satisfied Participants</title>
          <description>Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)</description>
          <population>Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>35mg HB Prilocaine</title>
        </group>
        <group group_id="E2">
          <title>40mg HB Prilocaine</title>
        </group>
        <group group_id="E3">
          <title>45mg HB Prilocaine</title>
        </group>
        <group group_id="E4">
          <title>50mg HB Prilocaine</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Panayota Kapessidou</name_or_title>
      <organization>Centre Hospitalier Universitaire Saint Pierre</organization>
      <phone>+32.2.535 ext 3750</phone>
      <email>pkapessi@ulb.ac.be</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036384
org study id: NB076201627436
nct id: NCT03036384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Success of Anesthesia
time frame: during surgery (average 1 hour)
description: 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
measure: Sensitive Block Duration
time frame: Until complete release of sensory block (T12-S1) (average 4 hours)
description: Level of Sensory block assessed as loss of sensation to cold, 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).
measure: Sensitive Block at End of Surgery
time frame: Until complete release of sensory block (T12-S1) (average 4 hours)
description: Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)
measure: Motor Block Duration
time frame: Until complete release of motor block (Bromage scale = 1; average 4 hours)
description: Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.
measure: Bromage Motor Block Level at End of Surgery
time frame: Until complete release of motor block (average 4 hours)
description: Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.
measure: Newborn Apgar Score
time frame: up to 10 minutes after baby extraction
description: Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).
The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).
measure: Newborn Methemoglobinemia (MetHb)
time frame: average 1 hour
description: Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.
measure: Number of Participants Needing Vasopressors
time frame: during surgery (average 1 hour)
description: 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). Vasopressors were given for patients with low blood pressure.
A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia).
measure: Number of Participants With Transient Neurologic Symptoms (TNS)
time frame: up to 5 Days
description: TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5
measure: Number of Participants With Nausea or Vomiting
time frame: up to 24 hours after surgery
description: 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)
measure: Number of Participants With Pruritus
time frame: Up to 24 hours after surgery
description: 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)
measure: Number of Participants With Urinary Retention
time frame: Up to 24 hours after surgery
description: All parturients will be questioned for urinary retention (yes or no)
measure: Number of Participants With Dizziness
time frame: Up to 24 hours after surgery
description: All parturients will be questioned for dizziness (yes or no)
measure: Number of Satisfied Participants
time frame: up to 1 hour after surgery
description: Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)
arm group label: Cohort 1 : HB prilocaine 2%, 45mg
arm group type: Experimental
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.
arm group label: Cohort 2 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 3 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 4 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 5 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 6 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 7 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 8 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 9 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
arm group label: Cohort 10 : HB prilocaine 2%, (30-55mg)
arm group type: Experimental
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.
intervention type: Drug
intervention name: HB Prilocaine 2% (varying dose)
description: Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
arm group label: Cohort 10 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 2 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 3 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 4 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 5 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 6 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 7 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 8 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 9 : HB prilocaine 2%, (30-55mg)
other name: Tachipri
intervention type: Drug
intervention name: HB Prilocaine 2%
description: The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
arm group label: Cohort 1 : HB prilocaine 2%, 45mg
other name: Tachipri
intervention type: Drug
intervention name: Sufentanil
description: 2.5µg sufentanyl
arm group label: Cohort 1 : HB prilocaine 2%, 45mg
arm group label: Cohort 10 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 2 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 3 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 4 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 5 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 6 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 7 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 8 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 9 : HB prilocaine 2%, (30-55mg)
intervention type: Drug
intervention name: Morphine
description: 100 µg Morphine
arm group label: Cohort 1 : HB prilocaine 2%, 45mg
arm group label: Cohort 10 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 2 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 3 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 4 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 5 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 6 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 7 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 8 : HB prilocaine 2%, (30-55mg)
arm group label: Cohort 9 : HB prilocaine 2%, (30-55mg)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Panayota Kapessidou, MD,PhD
role: Study Director
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
last name: Philippe Goffard, MD
role: Principal Investigator
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
facility: 
country: Belgium
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Sufentanil
mesh term: Morphine
mesh term: Prilocaine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 