<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/NCT02973048</url>
  </required_header>
  <id_info>
    <org_study_id>B076201627677</org_study_id>
    <nct_id>NCT02973048</nct_id>
  </id_info>
  <brief_title>Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia</brief_title>
  <official_title>Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial</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>
      Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia&#xD;
      using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite&#xD;
      effective surgical anesthesia, bupivacaine is associated with long duration motor block and&#xD;
      dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its&#xD;
      new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and&#xD;
      faster regression of motor block compared to other local anesthetics without noteworthy&#xD;
      side-effects when used intrathecally. The aim of this randomized, multicenter, powered&#xD;
      clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric&#xD;
      bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid&#xD;
      rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers&#xD;
      shorter motor block and more rapid rehabilitation than bupivacaine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">November 8, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Regression of Motor Block</measure>
    <time_frame>until complete regression of motor block (up to 4 hours)</time_frame>
    <description>Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Successful Anesthesia (Successful Sensory Block)</measure>
    <time_frame>From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)</time_frame>
    <description>Time between spinal injection and reached bilateral T4 sensory level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia</measure>
    <time_frame>until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
    <description>Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured 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). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.&#xD;
To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.&#xD;
The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Sensory Block</measure>
    <time_frame>until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
    <description>Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Motor Block Onset</measure>
    <time_frame>From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)</time_frame>
    <description>Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Hypotension and Use of Vasopressors</measure>
    <time_frame>up to 2 hours after surgery</time_frame>
    <description>Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic 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 Urinary Retention</measure>
    <time_frame>up to 4 hours after surgery</time_frame>
    <description>All parturients will be questioned and examined for urinary retention (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Walk</measure>
    <time_frame>up to 24h after surgery</time_frame>
    <description>Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)</measure>
    <time_frame>up to 24 hours after surgery</time_frame>
    <description>All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)</measure>
    <time_frame>up to 72 hours after surgery</time_frame>
    <description>Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)</measure>
    <time_frame>up to 72 hours after surgery</time_frame>
    <description>Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Transient Neurologic Symptoms (TNS)</measure>
    <time_frame>up to 15 Days after surgery</time_frame>
    <description>Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain as Assessed by Visual Analogue Scale</measure>
    <time_frame>up to 24 hours after surgery</time_frame>
    <description>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). Patient will receive additional analgesic treatment above VAS&gt;3.</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 in obstetrics, and expressed as a percentage of total hemoglobinemia.&#xD;
Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn Umbilical pH</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Surgery</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Time between incision and end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Spinal Injection to Baby Delivery</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Time between spinal injection and baby delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Baby Delivery to End of Surgery</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Time between baby delivery, and the end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Blood Loss</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Total blood loss (milliliters) during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obstetrician Satisfaction</measure>
    <time_frame>average 1 hour</time_frame>
    <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midwife Satisfaction</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pregnant Women</condition>
  <condition>Pain</condition>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Hyperbaric bupivacaine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperbaric prilocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperbaric bupivacaine</intervention_name>
    <description>The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
    <arm_group_label>Hyperbaric bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperbaric prilocaine</intervention_name>
    <description>The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
    <arm_group_label>Hyperbaric prilocaine</arm_group_label>
    <other_name>Tachipri</other_name>
  </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;110 kg&#xD;
&#xD;
          -  Height between 160 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;
          -  Intrauterine growth retardation&#xD;
&#xD;
          -  Patient in labour&#xD;
&#xD;
          -  Membrane rupture&#xD;
&#xD;
          -  Known allergy to local anaesthetics&#xD;
&#xD;
          -  Standard contraindications to neuraxial block.&#xD;
&#xD;
          -  Disagreement of the patient&#xD;
&#xD;
          -  Neurological impairment&#xD;
&#xD;
          -  Gestational low blood pressure&#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</city>
        <state>Brussels Capital</state>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Ste-Anne/St-Remi</name>
      <address>
        <city>Anderlecht</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.</citation>
    <PMID>14570791</PMID>
  </reference>
  <reference>
    <citation>Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.</citation>
    <PMID>24906303</PMID>
  </reference>
  <reference>
    <citation>Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.</citation>
    <PMID>27044397</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>May 18, 2020</results_first_submitted>
  <results_first_submitted_qc>July 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2020</results_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarean delivery</keyword>
  <keyword>Spinal anesthesia</keyword>
  <keyword>Local anesthetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT02973048/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were recruited at CHU Saint-Pierre and Sainte-Anne Saint-Rémy hospitals (Brussels). Of 88 patients assessed for eligibility, only 40 were randomized to treatment (17 not meeting inclusion criteria and 31 declined to participate)</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Hyperbaric Bupivacaine</title>
          <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </group>
        <group group_id="P2">
          <title>Hyperbaric Prilocaine</title>
          <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Epidural catheter insertion failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hyperbaric Bupivacaine</title>
          <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </group>
        <group group_id="B2">
          <title>Hyperbaric Prilocaine</title>
          <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </group>
        <group group_id="B3">
          <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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.5" lower_limit="32" upper_limit="38"/>
                    <measurement group_id="B2" value="32" lower_limit="28.75" upper_limit="35.25"/>
                    <measurement group_id="B3" value="36" lower_limit="29.75" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" 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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.8" spread="12.85"/>
                    <measurement group_id="B2" value="76.2" spread="13.4"/>
                    <measurement group_id="B3" value="75.5" spread="12.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="164" lower_limit="161" upper_limit="166.25"/>
                    <measurement group_id="B2" value="164" lower_limit="160" upper_limit="168.25"/>
                    <measurement group_id="B3" value="164" lower_limit="160" upper_limit="167.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.37" lower_limit="23.77" upper_limit="30.58"/>
                    <measurement group_id="B2" value="26.19" lower_limit="24.75" upper_limit="30.58"/>
                    <measurement group_id="B3" value="26.26" lower_limit="24.61" upper_limit="30.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists physical status (ASA) II</title>
          <description>The American Society of Anesthesiologists (ASA) physical status classification system was developed to offer clinicians a simple categorization of a patient's physiological status that can be helpful in predicting operative risk.&#xD;
ASA 1: Normal healthy patient, ASA 2: Patient with a mild systemic disease ASA 3: Patient with a severe systemic disease not life-threatening ASA 4: Patient with a severe systemic disease being a constant threat to life. ASA 5: Moribund patient&#xD;
Pregnancy of &gt; 20 amenorrhea age is considered an ASA II grade; parturients of ASA &gt; II were excluded from study</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational Age (GA)</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" lower_limit="38" upper_limit="39"/>
                    <measurement group_id="B2" value="39" lower_limit="38" upper_limit="39"/>
                    <measurement group_id="B3" value="39" lower_limit="38" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestity</title>
          <units>Pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>Deliveries</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous c-Section</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Regression of Motor Block</title>
        <description>Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block</description>
        <time_frame>until complete regression of motor block (up to 4 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Regression of Motor Block</title>
          <description>Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180" lower_limit="142.5" upper_limit="239.5"/>
                    <measurement group_id="O2" value="130" lower_limit="120" upper_limit="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Successful Anesthesia (Successful Sensory Block)</title>
        <description>Time between spinal injection and reached bilateral T4 sensory level.</description>
        <time_frame>From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Successful Anesthesia (Successful Sensory Block)</title>
          <description>Time between spinal injection and reached bilateral T4 sensory level.</description>
          <units>minutes</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.63" spread="3.48"/>
                    <measurement group_id="O2" value="11.18" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia</title>
        <description>Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured 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). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.&#xD;
To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.&#xD;
The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.</description>
        <time_frame>until complete release of sensory block (T12-S1) (average 4 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia</title>
          <description>Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured 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). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.&#xD;
To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.&#xD;
The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.</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="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensory level dermatome C5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome C6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome C7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome C8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory level dermatome T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Sensory Block</title>
        <description>Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 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>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Sensory Block</title>
          <description>Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).</description>
          <units>minutes</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.95" spread="51.48"/>
                    <measurement group_id="O2" value="169.59" spread="32.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Motor Block Onset</title>
        <description>Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia</description>
        <time_frame>From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Motor Block Onset</title>
          <description>Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="10" upper_limit="16"/>
                    <measurement group_id="O2" value="10" lower_limit="10" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Hypotension and Use of Vasopressors</title>
        <description>Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)</description>
        <time_frame>up to 2 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Hypotension and Use of Vasopressors</title>
          <description>Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)</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="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasopressors use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="10"/>
                  </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 and examined for urinary retention (yes or no)</description>
        <time_frame>up to 4 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Urinary Retention</title>
          <description>All parturients will be questioned and examined for urinary retention (yes or no)</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="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Walk</title>
        <description>Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.</description>
        <time_frame>up to 24h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Walk</title>
          <description>Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.</description>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318" lower_limit="194" upper_limit="420"/>
                    <measurement group_id="O2" value="198" lower_limit="175.5" upper_limit="250.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)</title>
        <description>All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)</description>
        <time_frame>up to 24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)</title>
          <description>All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="8" upper_limit="9"/>
                    <measurement group_id="O2" value="9" lower_limit="8" upper_limit="9.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)</title>
        <description>Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)</description>
        <time_frame>up to 72 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)</title>
          <description>Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="O2" value="9" lower_limit="8" upper_limit="9.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)</title>
        <description>Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)</description>
        <time_frame>up to 72 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)</title>
          <description>Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)</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="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Peroperative</title>
              <category_list>
                <category>
                  <title>score 0 (no symptom)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 1 (symptom with no necessary treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 2 (symptom present and treated)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <title>score 0 (no symptom)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 1 (symptom with no necessary treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 2 (symptom present and treated)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <title>score 0 (no symptom)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 1 (symptom with no necessary treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 2 (symptom present and treated)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <title>score 0 (no symptom)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 1 (symptom with no necessary treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 2 (symptom present and treated)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <title>score 0 (no symptom)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 1 (symptom with no necessary treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>score 2 (symptom present and treated)</title>
                  <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 Transient Neurologic Symptoms (TNS)</title>
        <description>Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. 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.</description>
        <time_frame>up to 15 Days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Transient Neurologic Symptoms (TNS)</title>
          <description>Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. 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.</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="19"/>
                <count group_id="O2" value="17"/>
              </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>Pain as Assessed by Visual Analogue Scale</title>
        <description>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). Patient will receive additional analgesic treatment above VAS&gt;3.</description>
        <time_frame>up to 24 hours after surgery</time_frame>
        <population>VAS are presented only at 1 Hour, 2 Hours , 3 Hours and 4 Hours post-surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain as Assessed by Visual Analogue Scale</title>
          <description>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). Patient will receive additional analgesic treatment above VAS&gt;3.</description>
          <population>VAS are presented only at 1 Hour, 2 Hours , 3 Hours and 4 Hours post-surgery</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS at 1 Hour</title>
              <category_list>
                <category>
                  <title>VAS=0 (no pain)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS 1-2 (No additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS &gt;3 (additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS at 2 Hours</title>
              <category_list>
                <category>
                  <title>VAS=0 (no pain)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS 1-2 (No additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS &gt;3 (additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS at 3 Hours</title>
              <category_list>
                <category>
                  <title>VAS=0 (no pain)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS 1-2 (No additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS &gt;3 (additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS at 4 Hours</title>
              <category_list>
                <category>
                  <title>VAS=0 (no pain)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS 1-2 (No additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VAS &gt;3 (additional analgesic treatment)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </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>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </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>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Apgar at 1 minute</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="9" upper_limit="9"/>
                    <measurement group_id="O2" value="9" lower_limit="9" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apgar at 3 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="10" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="10" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apgar at 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="10" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="10" upper_limit="10"/>
                  </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 in obstetrics, and expressed as a percentage of total hemoglobinemia.&#xD;
Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </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 in obstetrics, and expressed as a percentage of total hemoglobinemia.&#xD;
Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.</description>
          <units>percentage of MetHb</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.7" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.6" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Newborn Umbilical pH</title>
        <description>Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Newborn Umbilical pH</title>
          <description>Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value</description>
          <units>pH</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" lower_limit="7.29" upper_limit="7.34"/>
                    <measurement group_id="O2" value="7.32" lower_limit="7.29" upper_limit="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Surgery</title>
        <description>Time between incision and end of surgery</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Surgery</title>
          <description>Time between incision and end of surgery</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="40.5" upper_limit="56.5"/>
                    <measurement group_id="O2" value="50" lower_limit="44" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Spinal Injection to Baby Delivery</title>
        <description>Time between spinal injection and baby delivery</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Spinal Injection to Baby Delivery</title>
          <description>Time between spinal injection and baby delivery</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="22" upper_limit="27"/>
                    <measurement group_id="O2" value="25" lower_limit="24" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Baby Delivery to End of Surgery</title>
        <description>Time between baby delivery, and the end of surgery</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Baby Delivery to End of Surgery</title>
          <description>Time between baby delivery, and the end of surgery</description>
          <units>minutes</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.68" spread="10.19"/>
                    <measurement group_id="O2" value="38.24" spread="6.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Blood Loss</title>
        <description>Total blood loss (milliliters) during surgery</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Blood Loss</title>
          <description>Total blood loss (milliliters) during surgery</description>
          <units>milliliters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415" lower_limit="312.5" upper_limit="746.25"/>
                    <measurement group_id="O2" value="485" lower_limit="305" upper_limit="562.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Obstetrician Satisfaction</title>
        <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery</description>
        <time_frame>average 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Obstetrician Satisfaction</title>
          <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Midwife Satisfaction</title>
        <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3</description>
        <time_frame>72 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Bupivacaine</title>
            <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
          <group group_id="O2">
            <title>Hyperbaric Prilocaine</title>
            <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
          </group>
        </group_list>
        <measure>
          <title>Midwife Satisfaction</title>
          <description>Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.5" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event were collected from spinal injection until 15 Days following the day of surgery.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hyperbaric Bupivacaine</title>
          <description>Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </group>
        <group group_id="E2">
          <title>Hyperbaric Prilocaine</title>
          <description>Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.&#xD;
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.</description>
        </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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient neurologic symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </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/NCT02973048
org study id: B076201627677
nct id: NCT02973048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia
      using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite
      effective surgical anesthesia, bupivacaine is associated with long duration motor block and
      dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its
      new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and
      faster regression of motor block compared to other local anesthetics without noteworthy
      side-effects when used intrathecally. The aim of this randomized, multicenter, powered
      clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric
      bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid
      rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers
      shorter motor block and more rapid rehabilitation than bupivacaine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Time to Regression of Motor Block
time frame: until complete regression of motor block (up to 4 hours)
description: Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
measure: Time to Successful Anesthesia (Successful Sensory Block)
time frame: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
description: Time between spinal injection and reached bilateral T4 sensory level.
measure: Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
time frame: until complete release of sensory block (T12-S1) (average 4 hours)
description: Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured 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). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.
To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.
The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.
measure: Time to Resolution of Sensory Block
time frame: until complete release of sensory block (T12-S1) (average 4 hours)
description: Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).
measure: Time to Motor Block Onset
time frame: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
description: Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia
measure: Number of Patients With Hypotension and Use of Vasopressors
time frame: up to 2 hours after surgery
description: Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)
measure: Number of Participants With Urinary Retention
time frame: up to 4 hours after surgery
description: All parturients will be questioned and examined for urinary retention (yes or no)
measure: Time to First Walk
time frame: up to 24h after surgery
description: Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.
measure: Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
time frame: up to 24 hours after surgery
description: All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)
measure: Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
time frame: up to 72 hours after surgery
description: Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)
measure: Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
time frame: up to 72 hours after surgery
description: Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)
measure: Number of Participants With Transient Neurologic Symptoms (TNS)
time frame: up to 15 Days after surgery
description: Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. 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.
measure: Pain as Assessed by Visual Analogue Scale
time frame: up to 24 hours after surgery
description: 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). Patient will receive additional analgesic treatment above VAS>3.
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 in obstetrics, and expressed as a percentage of total hemoglobinemia.
Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.
measure: Newborn Umbilical pH
time frame: average 1 hour
description: Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
measure: Time of Surgery
time frame: average 1 hour
description: Time between incision and end of surgery
measure: Time From Spinal Injection to Baby Delivery
time frame: average 1 hour
description: Time between spinal injection and baby delivery
measure: Time From Baby Delivery to End of Surgery
time frame: average 1 hour
description: Time between baby delivery, and the end of surgery
measure: Total Blood Loss
time frame: average 1 hour
description: Total blood loss (milliliters) during surgery
measure: Obstetrician Satisfaction
time frame: average 1 hour
description: Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
measure: Midwife Satisfaction
time frame: 72 hours after surgery
description: Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
arm group label: Hyperbaric bupivacaine
arm group type: Placebo Comparator
description: Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
arm group label: Hyperbaric prilocaine
arm group type: Active Comparator
description: Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
intervention type: Drug
intervention name: Hyperbaric bupivacaine
description: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
arm group label: Hyperbaric bupivacaine
other name: Marcaine
intervention type: Drug
intervention name: Hyperbaric prilocaine
description: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
arm group label: Hyperbaric prilocaine
other name: Tachipri
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: 
facility: 
country: Belgium
citation: Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.
PMID: 14570791
citation: Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
PMID: 24906303
citation: Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.
PMID: 27044397
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Bupivacaine
mesh term: Prilocaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 