<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/NCT02984267</url>
  </required_header>
  <id_info>
    <org_study_id>OBUS1123</org_study_id>
    <nct_id>NCT02984267</nct_id>
  </id_info>
  <brief_title>Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40</brief_title>
  <official_title>Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas J. Vernon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Penn Allegheny Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Placement of labor epidurals is a very common daily practice in obstetrical anesthesia.&#xD;
      Currently, these epidurals are placed based upon palpation of landmarks to determine midline&#xD;
      and the correct spinal level for placement. Palpation of these landmarks can be difficult,&#xD;
      however, particularly in morbidly obese patients who have significant amounts of soft tissue&#xD;
      overlying them. This study seeks to use ultrasound guidance to examine the spine prior to&#xD;
      epidural placement, and see what effects this has compared to palpation alone with respect to&#xD;
      procedure time, number of attempts, success rate in the first attempt, failure rate,&#xD;
      complication rate, patient anxiety levels, and patient satisfaction levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 15, 2017</completion_date>
  <primary_completion_date type="Actual">April 15, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Time Required for Epidural Catheter Placement</measure>
    <time_frame>Assessed immediately during epidural catheter placement</time_frame>
    <description>Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidural Procedure Time</measure>
    <time_frame>Assessed immediately during epidural catheter placement</time_frame>
    <description>Time required to successfully place the epidural catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Attempts at Epidural Catheter Placement</measure>
    <time_frame>Assessed immediately during epidural catheter placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt</measure>
    <time_frame>Assessed immediately during epidural catheter placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Assessed immediately during epidural catheter placement and within 24 hours after delivery</time_frame>
    <description>Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural Failure Rate</measure>
    <time_frame>Assessed within 24 hours after delivery</time_frame>
    <description>Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural Catheter Placement Satisfaction Level</measure>
    <time_frame>Assessed immediately following epidural catheter placement</time_frame>
    <description>Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Anxiety Level</measure>
    <time_frame>Assessed immediately following epidural catheter placement</time_frame>
    <description>Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palpation or Ultrasound Time</measure>
    <time_frame>Assessed immediately prior to epidural catheter placement</time_frame>
    <description>The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Anesthesia Experience Satisfaction</measure>
    <time_frame>Measured within 24 hours of delivery</time_frame>
    <description>Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>Ultrasound Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Palpation Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group that will have their epidural placed in the usual fashion based on palpation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
    <arm_group_label>Ultrasound Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palpation</intervention_name>
    <description>Using palpation only to evaluate the spine prior to epidural placement</description>
    <arm_group_label>Palpation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current (pregnant) BMI ≥ 40&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  ASA score of 3 or less&#xD;
&#xD;
          -  Full term pregnancy (37 weeks gestational age or greater)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known scoliosis&#xD;
&#xD;
          -  Known contraindications to neuraxial blockade&#xD;
&#xD;
          -  Intrauterine fetal demise or non-viable fetus.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Magee Women's Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>March 30, 2018</results_first_submitted>
  <results_first_submitted_qc>June 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2018</results_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Thomas J. Vernon</investigator_full_name>
    <investigator_title>OB Anesthesia Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02984267/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02984267/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultrasound Group</title>
          <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
        </group>
        <group group_id="P2">
          <title>Palpation Group</title>
          <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Ultrasound 43.75% (7/16); Palpation 56.25% (9/16)</population>
      <group_list>
        <group group_id="B1">
          <title>Ultrasound Group</title>
          <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
        </group>
        <group group_id="B2">
          <title>Palpation Group</title>
          <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</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="7"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="16"/>
          </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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3" spread="4.7"/>
                    <measurement group_id="B2" value="29.9" spread="5.5"/>
                    <measurement group_id="B3" value="27.9" spread="5.4"/>
                  </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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </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 (NIH/OMB)</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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</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>Gravidity</title>
          <units>Number of pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B2" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>Number of children born</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated gestational age</title>
          <units>Weeks</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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.6" spread="0.8"/>
                    <measurement group_id="B2" value="38.1" spread="1.1"/>
                    <measurement group_id="B3" value="38.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="122.0" spread="17.1"/>
                    <measurement group_id="B2" value="120.6" spread="15.8"/>
                    <measurement group_id="B3" value="121.2" spread="15.8"/>
                  </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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.7" spread="5.3"/>
                    <measurement group_id="B2" value="162.1" spread="5.3"/>
                    <measurement group_id="B3" value="162.8" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.6" spread="7.4"/>
                    <measurement group_id="B2" value="45.9" spread="6.3"/>
                    <measurement group_id="B3" value="45.8" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists (ASA) physical status</title>
          <description>ASA1, ASA2, and ASA3 are all categories that participants could fall into based on the status of their overall health. ASA1 indicates a normal, healthy patient. ASA2 indicates a patient with mild systemic disease (examples include but are not limited to pregnancy, current smoker, obesity with a BMI &gt;30 but &lt;40, and well controlled diabetes or hypertension). ASA3 indicates a patient with severe systemic disease (examples include but are not limited to poorly controlled diabetes or hypertension, chronic obstructive pulmonary disorder, morbid obesity with a BMI greater than or equal to 40).</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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ASA1</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>
                  <title>ASA2</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>
                  <title>ASA3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>External landmarks visible</title>
          <description>The back of the patient is visually examined to determine if the outline of the spinous processes of the vertebrae can be seen through the skin.</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="7"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</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>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Palpable interspace</title>
          <description>A patient has &quot;palpable interspaces&quot; when the spinous processes of the vertebrae, and thus the interspaces between them, can easily be physically felt by the provider through the patient's skin.</description>
          <population>Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).</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="9"/>
                    <count group_id="B3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Time Required for Epidural Catheter Placement</title>
        <description>Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter</description>
        <time_frame>Assessed immediately during epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Total Time Required for Epidural Catheter Placement</title>
          <description>Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="3.5"/>
                    <measurement group_id="O2" value="11.0" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epidural Procedure Time</title>
        <description>Time required to successfully place the epidural catheter</description>
        <time_frame>Assessed immediately during epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Epidural Procedure Time</title>
          <description>Time required to successfully place the epidural catheter</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="3.5"/>
                    <measurement group_id="O2" value="10.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Attempts at Epidural Catheter Placement</title>
        <time_frame>Assessed immediately during epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Attempts at Epidural Catheter Placement</title>
          <units>Number of attempts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="5" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt</title>
        <time_frame>Assessed immediately during epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications</title>
        <description>Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.</description>
        <time_frame>Assessed immediately during epidural catheter placement and within 24 hours after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Complications</title>
          <description>Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.</description>
          <units>Complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epidural Failure Rate</title>
        <description>Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported</description>
        <time_frame>Assessed within 24 hours after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Epidural Failure Rate</title>
          <description>Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported</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="7"/>
                <count group_id="O2" value="9"/>
              </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>Epidural Catheter Placement Satisfaction Level</title>
        <description>Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.</description>
        <time_frame>Assessed immediately following epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Epidural Catheter Placement Satisfaction Level</title>
          <description>Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="1.2"/>
                    <measurement group_id="O2" value="7.3" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Anxiety Level</title>
        <description>Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.</description>
        <time_frame>Assessed immediately following epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Anxiety Level</title>
          <description>Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.9"/>
                    <measurement group_id="O2" value="6.0" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Palpation or Ultrasound Time</title>
        <description>The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion</description>
        <time_frame>Assessed immediately prior to epidural catheter placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Palpation or Ultrasound Time</title>
          <description>The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.6"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Anesthesia Experience Satisfaction</title>
        <description>Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.</description>
        <time_frame>Measured within 24 hours of delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound Group</title>
            <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
          </group>
          <group group_id="O2">
            <title>Palpation Group</title>
            <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Anesthesia Experience Satisfaction</title>
          <description>Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" spread="11.8"/>
                    <measurement group_id="O2" value="74.3" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the patients current hospitalization (typically 2-3 days)</time_frame>
      <desc>All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Ultrasound Group</title>
          <description>The interventional group that will have their spine evaluated by ultrasound prior to epidural placement&#xD;
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement</description>
        </group>
        <group group_id="E2">
          <title>Palpation Group</title>
          <description>The control group that will have their epidural placed in the usual fashion based on palpation&#xD;
Palpation: Using palpation only to evaluate the spine prior to epidural placement</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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Inadvertent dural puncture</sub_title>
                <description>Number of participants sustaining an inadvertent dural puncture during the procedure resulting in the formation of a post-dural puncture headache</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <description>Number of patients experiencing a transient paresthesia in their back or leg(s) during epidural catheter placement</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </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. Thomas Vernon</name_or_title>
      <organization>Arizona Anesthesia Consultants</organization>
      <phone>480-570-7082</phone>
      <email>tvernon@azanesthesia.net</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/NCT02984267
org study id: OBUS1123
nct id: NCT02984267
lead sponsor: 
collaborator: 
has dmc: No
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia.
      Currently, these epidurals are placed based upon palpation of landmarks to determine midline
      and the correct spinal level for placement. Palpation of these landmarks can be difficult,
      however, particularly in morbidly obese patients who have significant amounts of soft tissue
      overlying them. This study seeks to use ultrasound guidance to examine the spine prior to
      epidural placement, and see what effects this has compared to palpation alone with respect to
      procedure time, number of attempts, success rate in the first attempt, failure rate,
      complication rate, patient anxiety levels, and patient satisfaction levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Time Required for Epidural Catheter Placement
time frame: Assessed immediately during epidural catheter placement
description: Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
measure: Epidural Procedure Time
time frame: Assessed immediately during epidural catheter placement
description: Time required to successfully place the epidural catheter
measure: Number of Attempts at Epidural Catheter Placement
time frame: Assessed immediately during epidural catheter placement
measure: Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
time frame: Assessed immediately during epidural catheter placement
measure: Complications
time frame: Assessed immediately during epidural catheter placement and within 24 hours after delivery
description: Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
measure: Epidural Failure Rate
time frame: Assessed within 24 hours after delivery
description: Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
measure: Epidural Catheter Placement Satisfaction Level
time frame: Assessed immediately following epidural catheter placement
description: Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
measure: Patient Anxiety Level
time frame: Assessed immediately following epidural catheter placement
description: Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
measure: Palpation or Ultrasound Time
time frame: Assessed immediately prior to epidural catheter placement
description: The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
measure: Overall Anesthesia Experience Satisfaction
time frame: Measured within 24 hours of delivery
description: Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
arm group label: Ultrasound Group
arm group type: Experimental
description: The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
arm group label: Palpation Group
arm group type: Other
description: The control group that will have their epidural placed in the usual fashion based on palpation
intervention type: Device
intervention name: Ultrasound
description: Using ultrasound guidance to evaluate the spine prior to epidural placement
arm group label: Ultrasound Group
intervention type: Other
intervention name: Palpation
description: Using palpation only to evaluate the spine prior to epidural placement
arm group label: Palpation Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Thomas J. Vernon
investigator title: OB Anesthesia Fellow
mesh term: Labor Pain
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 