<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/NCT02207972</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #12-172</org_study_id>
    <nct_id>NCT02207972</nct_id>
  </id_info>
  <brief_title>Does Ultrasound Help With Placement of Labor Analgesia in Pregnant Patients?</brief_title>
  <official_title>Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle With Positive CSF Flow, Thereby Facilitating Correct Placement of the Catheter Compared to Catheter Placement Using Palpation of Anatomical Landmarks?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Luke's-Roosevelt Hospital Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators believe that ultrasound guided CSE technique will accurately place the&#xD;
      epidural needle in the midline position compared to epidural needle placement via palpation&#xD;
      of anatomical landmarks. This will result in positive CSF in the spinal needle, correct&#xD;
      placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural&#xD;
      anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140&#xD;
      surgical patients, a failure rate of 27% for lumbar epidural was described. However, the&#xD;
      definition of a failed epidural is broad. Different definitions include insufficient&#xD;
      analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia&#xD;
      failures may result from technical difficulties, insufficiencies or overdosing of local&#xD;
      anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter&#xD;
      through an intervertebral foramen or into the anterior epidural space. In an imaging study of&#xD;
      failed epidurals, incorrect catheter placement accounted for half of the failures, while the&#xD;
      remaining patients experienced suboptimal analgesia through a correctly positioned catheter.&#xD;
&#xD;
      The incidence of overall failure was lower in patients receiving combined spinal-epidural&#xD;
      (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased&#xD;
      failure rates for labor analgesia and comparable or decreased failure rates for surgical&#xD;
      anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed&#xD;
      that positive CSF flow in the spinal needle confirms correct epidural needle placement in the&#xD;
      epidural space and also confirms the epidural needle to be in the midline position. Placement&#xD;
      of the epidural needle in the midline position will minimize the incorrect placement of the&#xD;
      catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.&#xD;
&#xD;
      However, the practice of CSE and epidural catheter placement relies on the palpation of&#xD;
      anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe&#xD;
      placed &quot;off midline&quot; despite positive loss of resistance (LOR) that causes negative CSF flow&#xD;
      in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter&#xD;
      placement will result in a &quot;failed&quot; or suboptimal epidural analgesia.&#xD;
&#xD;
      Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US&#xD;
      imaging of the lumbar spine in different scanning planes facilitates the identification of&#xD;
      the landmarks necessary for appropriate epidural space location in pregnant patients. There&#xD;
      are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen&#xD;
      on the transverse approach, and the other seen on the longitudinal paramedian approach. The&#xD;
      ultrasound single-screen method using the transverse approach of the lumbar spine provides&#xD;
      reliable information regarding the landmarks required for labor epidurals. The correct&#xD;
      interspace and midline position are identified for correct placement of the CSE analgesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Accurate Epidural Placement</measure>
    <time_frame>2 hours</time_frame>
    <description>Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Successful First Attempt</measure>
    <time_frame>Immediate</time_frame>
    <description>The number of participants who had first attempt success to locate the epidural space and midline position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Without Angle Adjustments in Space Success</measure>
    <time_frame>immediate</time_frame>
    <description>the number of participants with successes without any readjustment of the angle in the space</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Use of Ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ultrasound used</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of Ultrasound</intervention_name>
    <description>The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.</description>
    <arm_group_label>Use of Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No ultrasound used</intervention_name>
    <description>Palpation of anatomical landmarks is used for placement of labor analgesia</description>
    <arm_group_label>No ultrasound used</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparious&#xD;
&#xD;
          -  Term (&gt;37 weeks gestation)&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Request for analgesia for labor pain&#xD;
&#xD;
          -  Maternal age 18 years or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparous&#xD;
&#xD;
          -  Preterm (&lt; 37 weeks gestation)&#xD;
&#xD;
          -  Presentation other than vertex (breech, transverse)&#xD;
&#xD;
          -  Active drug/alcohol dependence&#xD;
&#xD;
          -  Previous spinal surgeries&#xD;
&#xD;
          -  Known spinal deformities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Migdalia Saloum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Roosevelt Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount-Sinai Roosevelt hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>May 10, 2017</results_first_submitted>
  <results_first_submitted_qc>February 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2018</results_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnant</keyword>
  <keyword>labor</keyword>
  <keyword>Epidural</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients in labor requesting epidural will be offered to participate in the study for their neuraxial placement</recruitment_details>
      <pre_assignment_details>Once the patient agrees to be in the study, they will be randomized into one of the 2 arms (with or without ultrasound) for their neuraxial placement.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Use of Ultrasound</title>
          <description>Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.</description>
        </group>
        <group group_id="P2">
          <title>No Ultrasound Used</title>
          <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="24"/>
              </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>Use of Ultrasound</title>
          <description>Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.</description>
        </group>
        <group group_id="B2">
          <title>No Ultrasound Used</title>
          <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</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="22"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.83" lower_limit="19" upper_limit="39"/>
                    <measurement group_id="B2" value="31.85" lower_limit="19" upper_limit="39"/>
                    <measurement group_id="B3" value="31.84" lower_limit="19" upper_limit="39"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Accurate Epidural Placement</title>
        <description>Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Use of Ultrasound</title>
            <description>Woman requests epidural for pain relief Ultrasound guided CSE placed&#xD;
Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes</description>
          </group>
          <group group_id="O2">
            <title>No Ultrasound Used</title>
            <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Accurate Epidural Placement</title>
          <description>Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position</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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Successful First Attempt</title>
        <description>The number of participants who had first attempt success to locate the epidural space and midline position</description>
        <time_frame>Immediate</time_frame>
        <population>Pregnant patients in labor requesting neuraxial analgesia</population>
        <group_list>
          <group group_id="O1">
            <title>Use of Ultrasound</title>
            <description>Woman requests epidural for pain relief Ultrasound guided CSE placed&#xD;
Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes.</description>
          </group>
          <group group_id="O2">
            <title>No Ultrasound Used</title>
            <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful First Attempt</title>
          <description>The number of participants who had first attempt success to locate the epidural space and midline position</description>
          <population>Pregnant patients in labor requesting neuraxial analgesia</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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Without Angle Adjustments in Space Success</title>
        <description>the number of participants with successes without any readjustment of the angle in the space</description>
        <time_frame>immediate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Use of Ultrasound</title>
            <description>Woman requests epidural for pain relief Ultrasound guided CSE placed&#xD;
Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes.</description>
          </group>
          <group group_id="O2">
            <title>No Ultrasound Used</title>
            <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Without Angle Adjustments in Space Success</title>
          <description>the number of participants with successes without any readjustment of the angle in the space</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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Use of Ultrasound</title>
          <description>Woman requests epidural for pain relief Ultrasound guided CSE placed&#xD;
Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes.</description>
        </group>
        <group group_id="E2">
          <title>No Ultrasound Used</title>
          <description>Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks&#xD;
Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml&#xD;
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia</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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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 Barbara Orlando MD and PI</name_or_title>
      <organization>Mount Sinai West</organization>
      <phone>2125236915</phone>
      <email>barbara.orlando@mountsinai.org</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/NCT02207972
org study id: IRB #12-172
nct id: NCT02207972
lead sponsor: 
has dmc: No
The investigators believe that ultrasound guided CSE technique will accurately place the
      epidural needle in the midline position compared to epidural needle placement via palpation
      of anatomical landmarks. This will result in positive CSF in the spinal needle, correct
      placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.
Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural
      anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140
      surgical patients, a failure rate of 27% for lumbar epidural was described. However, the
      definition of a failed epidural is broad. Different definitions include insufficient
      analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia
      failures may result from technical difficulties, insufficiencies or overdosing of local
      anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter
      through an intervertebral foramen or into the anterior epidural space. In an imaging study of
      failed epidurals, incorrect catheter placement accounted for half of the failures, while the
      remaining patients experienced suboptimal analgesia through a correctly positioned catheter.

      The incidence of overall failure was lower in patients receiving combined spinal-epidural
      (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased
      failure rates for labor analgesia and comparable or decreased failure rates for surgical
      anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed
      that positive CSF flow in the spinal needle confirms correct epidural needle placement in the
      epidural space and also confirms the epidural needle to be in the midline position. Placement
      of the epidural needle in the midline position will minimize the incorrect placement of the
      catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.

      However, the practice of CSE and epidural catheter placement relies on the palpation of
      anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe
      placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow
      in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter
      placement will result in a "failed" or suboptimal epidural analgesia.

      Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US
      imaging of the lumbar spine in different scanning planes facilitates the identification of
      the landmarks necessary for appropriate epidural space location in pregnant patients. There
      are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen
      on the transverse approach, and the other seen on the longitudinal paramedian approach. The
      ultrasound single-screen method using the transverse approach of the lumbar spine provides
      reliable information regarding the landmarks required for labor epidurals. The correct
      interspace and midline position are identified for correct placement of the CSE analgesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Accurate Epidural Placement
time frame: 2 hours
description: Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position
measure: Number of Participants With Successful First Attempt
time frame: Immediate
description: The number of participants who had first attempt success to locate the epidural space and midline position
measure: Number of Participants Without Angle Adjustments in Space Success
time frame: immediate
description: the number of participants with successes without any readjustment of the angle in the space
arm group label: Use of Ultrasound
arm group type: Active Comparator
description: Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml
arm group label: No ultrasound used
arm group type: Active Comparator
description: Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml
intervention type: Device
intervention name: Use of Ultrasound
description: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
arm group label: Use of Ultrasound
intervention type: Procedure
intervention name: No ultrasound used
description: Palpation of anatomical landmarks is used for placement of labor analgesia
arm group label: No ultrasound used
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Migdalia Saloum, MD
role: Principal Investigator
affiliation: Mount Sinai Roosevelt Hospital
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 