<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/NCT03792191</url>
  </required_header>
  <id_info>
    <org_study_id>MD.18.02.29</org_study_id>
    <nct_id>NCT03792191</nct_id>
  </id_info>
  <brief_title>Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery</brief_title>
  <official_title>Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      The study will compare between preprocedural ultrasonography and the conventional palpation&#xD;
      technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, controlled, double-blind study will be conducted on ASA physical status&#xD;
      II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean&#xD;
      delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In&#xD;
      the ultrasonography group, lumbar spinal ultrasonography will be performed before&#xD;
      administration of spinal anesthesia. In the palpation group, conventional palpation of the&#xD;
      anatomical landmarks will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</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>Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the Spinal Procedure</measure>
    <time_frame>Assessed from enrollment in the study until completion of cesarean delivery</time_frame>
    <description>The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Assessed at 1 minute after intrathecal injection</time_frame>
    <description>Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vascular Puncture</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Paresthesia</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Number of participants with paresthesia reported by the subjects during performing the spinal procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow</measure>
    <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
    <description>Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Failed Spinal Block</measure>
    <time_frame>Assessed up to 20 minutes after intrathecal injection</time_frame>
    <description>Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Anesthesia, Spinal</condition>
  <condition>Cesarean Section</condition>
  <condition>Spinal Ultrasound</condition>
  <arm_group>
    <arm_group_label>Ultrasonography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Palpation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Lumbar Spinal Ultrasonography</intervention_name>
    <description>Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.</description>
    <arm_group_label>Ultrasonography</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Sham Ultrasound Procedure</intervention_name>
    <description>Moving the ultrasound probe on the patient's back with the machine in the freeze position.</description>
    <arm_group_label>Palpation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Landmark Palpation</intervention_name>
    <description>Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.</description>
    <arm_group_label>Palpation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Anesthesia</intervention_name>
    <description>Spinal anesthesia using a 25- or 22-gauge spinal needle</description>
    <arm_group_label>Palpation</arm_group_label>
    <arm_group_label>Ultrasonography</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Bupivacaine</intervention_name>
    <description>Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space</description>
    <arm_group_label>Palpation</arm_group_label>
    <arm_group_label>Ultrasonography</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Fentanyl</intervention_name>
    <description>Fentanyl 15 μg will be administered in the subarachnoid space</description>
    <arm_group_label>Palpation</arm_group_label>
    <arm_group_label>Ultrasonography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status II-III parturients&#xD;
&#xD;
          -  Full term singleton pregnancy&#xD;
&#xD;
          -  Body mass index ≥ 35 Kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 19 years&#xD;
&#xD;
          -  Women presenting in labor&#xD;
&#xD;
          -  Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial&#xD;
             pressure, or local skin infection)&#xD;
&#xD;
          -  Significant spinal deformities or previous spinal surgery&#xD;
&#xD;
          -  Preeclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed M Tawfik, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed A Tolba, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia, Mansoura University Hospitals</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <results_first_submitted>April 23, 2021</results_first_submitted>
  <results_first_submitted_qc>May 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2021</results_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mohamed Mohamed Tawfik</investigator_full_name>
    <investigator_title>Lecturer, Department of anesthesia and surgical intensive care, Primary investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</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>December 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03792191/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultrasonography</title>
          <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
        </group>
        <group group_id="P2">
          <title>Palpation</title>
          <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ultrasonography</title>
          <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
        </group>
        <group group_id="B2">
          <title>Palpation</title>
          <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</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="140"/>
            <count group_id="B2" value="140"/>
            <count group_id="B3" value="280"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</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="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.2" spread="5.9"/>
                    <measurement group_id="B2" value="30.3" spread="5.5"/>
                    <measurement group_id="B3" value="30.3" spread="5.7"/>
                  </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="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Egypt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</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="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.5" spread="6.1"/>
                    <measurement group_id="B2" value="160" spread="6.1"/>
                    <measurement group_id="B3" value="159.7" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102" lower_limit="80" upper_limit="160"/>
                    <measurement group_id="B2" value="103" lower_limit="76" upper_limit="140"/>
                    <measurement group_id="B3" value="102" lower_limit="76" upper_limit="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.2" lower_limit="35.2" upper_limit="61"/>
                    <measurement group_id="B2" value="39.2" lower_limit="35" upper_limit="58.3"/>
                    <measurement group_id="B3" value="39.8" lower_limit="35" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age (weeks)</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" lower_limit="37" upper_limit="41"/>
                    <measurement group_id="B2" value="38" lower_limit="37" upper_limit="40"/>
                    <measurement group_id="B3" value="38" lower_limit="37" upper_limit="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nulliparous</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="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ease of landmark palpation</title>
          <description>A 4-point scale (1 = the spinous processes and the interspaces can be identified by light palpation; 2 = the spinous processes and the interspaces can be identified by deep palpation; 3 = the spinous processes only can be identified by deep palpation, and the interspaces cannot be identified; 4 = neither the spinous processes nor the interspaces can be identified).</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="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow</title>
        <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow</title>
          <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</description>
          <units>needle passes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="34"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.62</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.00007</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.00005</ci_lower_limit>
            <ci_upper_limit>1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow</title>
        <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow</title>
          <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</description>
          <units>skin punctures</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass</title>
        <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass</title>
          <description>Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6</p_value>
            <method>Chi-squared, Corrected</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.036</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.079</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture</title>
        <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture</title>
          <description>Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.77</p_value>
            <method>Chi-squared, Corrected</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.021</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.125</ci_lower_limit>
            <ci_upper_limit>0.082</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of the Spinal Procedure</title>
        <description>The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow</description>
        <time_frame>Assessed from enrollment in the study until completion of cesarean delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of the Spinal Procedure</title>
          <description>The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow</description>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="26" upper_limit="734"/>
                    <measurement group_id="O2" value="59" lower_limit="19" upper_limit="700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.077</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1</ci_lower_limit>
            <ci_upper_limit>20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).</description>
        <time_frame>Assessed at 1 minute after intrathecal injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="4" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.00003</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.00001</ci_lower_limit>
            <ci_upper_limit>0.00003</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vascular Puncture</title>
        <description>Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vascular Puncture</title>
          <description>Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Paresthesia</title>
        <description>Number of participants with paresthesia reported by the subjects during performing the spinal procedure</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Paresthesia</title>
          <description>Number of participants with paresthesia reported by the subjects during performing the spinal procedure</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow</title>
        <description>Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.</description>
        <time_frame>Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow</title>
          <description>Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Failed Spinal Block</title>
        <description>Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.</description>
        <time_frame>Assessed up to 20 minutes after intrathecal injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasonography</title>
            <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Failed Spinal Block</title>
          <description>Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.</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="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment in the study until home discharge, up to 48 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ultrasonography</title>
          <description>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</description>
        </group>
        <group group_id="E2">
          <title>Palpation</title>
          <description>Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.&#xD;
Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position.&#xD;
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.&#xD;
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle&#xD;
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space&#xD;
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space</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="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
              </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>Dr. Mohamed Mohamed Tawfik</name_or_title>
      <organization>Mansoura University</organization>
      <phone>1001183400 ext 0020</phone>
      <email>m2tawfik@mans.edu.eg</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/NCT03792191
org study id: MD.18.02.29
nct id: NCT03792191
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will compare between preprocedural ultrasonography and the conventional palpation
      technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery
This randomized, controlled, double-blind study will be conducted on ASA physical status
      II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean
      delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In
      the ultrasonography group, lumbar spinal ultrasonography will be performed before
      administration of spinal anesthesia. In the palpation group, conventional palpation of the
      anatomical landmarks will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
measure: Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
measure: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
measure: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
measure: Duration of the Spinal Procedure
time frame: Assessed from enrollment in the study until completion of cesarean delivery
description: The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow
measure: Patient Satisfaction
time frame: Assessed at 1 minute after intrathecal injection
description: Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).
measure: Number of Participants With Vascular Puncture
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure
measure: Number of Participants With Paresthesia
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Number of participants with paresthesia reported by the subjects during performing the spinal procedure
measure: Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow
time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
description: Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.
measure: Number of Participants With Failed Spinal Block
time frame: Assessed up to 20 minutes after intrathecal injection
description: Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.
arm group label: Ultrasonography
arm group type: Experimental
description: Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
arm group label: Palpation
arm group type: Active Comparator
description: Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
intervention type: Radiation
intervention name: Lumbar Spinal Ultrasonography
description: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
arm group label: Ultrasonography
intervention type: Radiation
intervention name: Sham Ultrasound Procedure
description: Moving the ultrasound probe on the patient's back with the machine in the freeze position.
arm group label: Palpation
intervention type: Procedure
intervention name: Conventional Landmark Palpation
description: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
arm group label: Palpation
intervention type: Procedure
intervention name: Spinal Anesthesia
description: Spinal anesthesia using a 25- or 22-gauge spinal needle
arm group label: Palpation
arm group label: Ultrasonography
intervention type: Drug
intervention name: Intrathecal Bupivacaine
description: Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
arm group label: Palpation
arm group label: Ultrasonography
intervention type: Drug
intervention name: Intrathecal Fentanyl
description: Fentanyl 15 μg will be administered in the subarachnoid space
arm group label: Palpation
arm group label: Ultrasonography
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed M Tawfik, MD
role: Study Director
affiliation: Mansoura University Hospital
last name: Mohamed A Tolba, MSc
role: Principal Investigator
affiliation: Mansoura University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mohamed Mohamed Tawfik
investigator title: Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
mesh term: Fentanyl
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 