<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/NCT03789955</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1551</org_study_id>
    <nct_id>NCT03789955</nct_id>
  </id_info>
  <brief_title>The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess</brief_title>
  <official_title>Comparison of Contralateral Oblique View With the Lateral View for Mid-thoracic Epidural Assess: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to compare contralateral oblique view with the lateral view&#xD;
      for fluoroscopic guided mid-thoracic epidural assess.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A thoracic epidural assess (block or catheter insertion) is a widely used intervention to&#xD;
      reduce pain in patients with postherpetic neuralgia or who underwent chest and upper&#xD;
      abdominal surgery.&#xD;
&#xD;
      In order to achieve the correct procedure, accurate access to the thoracic epidural space is&#xD;
      needed. However, a thoracic epidural assess is a relatively more difficult procedure than&#xD;
      procedures used in other regions, because the spinous process of the thoracic vertebra is&#xD;
      longer than that of the lumbar vertebra, and the area through which the needle can approach&#xD;
      the epidural space is relatively smaller due to an acute angle and larger distance between&#xD;
      the skin and the epidural space. The midthoracic region (T4-8) is the most difficult area&#xD;
      when performing this procedure.&#xD;
&#xD;
      To overcome this issue, a method of approaching the thoracic epidural space through the&#xD;
      contralateral oblique view (CLO view) has been introduced, however, unlike the cervical or&#xD;
      lumbar spine, advantages of the CLO view over the lateral view or the optimal angle of the&#xD;
      CLO view have not yet been studied. Therefore, we planned this study to investigate the&#xD;
      advantages of the CLO view compared with the lateral view and to determine the optimal angles&#xD;
      of the CLO view when fluoroscopic guided mid-thoracic epidural assess.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">November 7, 2019</completion_date>
  <primary_completion_date type="Actual">November 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance between the tip of epidural needle and the baseline (CLO view - ventral interlaminar line, lateral view - spinolaminar line) at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)</measure>
    <time_frame>One day after the procedure</time_frame>
    <description>Location of the needle tip was defined as being significantly before the baseline (-2), just before the baseline (-1), on the baseline (0), just after the baseline (+1), or significantly after the baseline (+2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)</measure>
    <time_frame>One day after the procedure</time_frame>
    <description>The clarity of the needle tip was subjectively graded as 1 (clearly visualized without ambiguity), 2 (poorly visualized or visualized with effort), or 3 (not visualized).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Herpes Zoster</condition>
  <condition>Postherpetic Neuralgia</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Fluoroscopic-guided TEB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After assessment of the epidural space using the loss of resistance technique with air under fluoroscopic guidance, six fluoroscopic views will be obtained: true anteroposterior, contralateral oblique (CLO) at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral for comparison CLO view with lateral view.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluoroscopic-guided TEB</intervention_name>
    <description>When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.</description>
    <arm_group_label>Fluoroscopic-guided TEB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for mid thoracic (T4-T8) epidural block or catheter insertion&#xD;
&#xD;
          -  20 ≤ age &lt;80&#xD;
&#xD;
          -  Presence of thoracic MRI or CT&#xD;
&#xD;
          -  When obtaining informed consent voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to local anesthetics and contrast dye, and steroid&#xD;
&#xD;
          -  Use of anticoagulants or antiplatelet medication, coagulopathy&#xD;
&#xD;
          -  Infection at the insertion site&#xD;
&#xD;
          -  Neurological or psychiatric disorders&#xD;
&#xD;
          -  Prior spine instrumentation&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seong-Soo Choi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan medical center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seong-Soo Choi</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Seong-Soo Choi, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Fluoroscopy</keyword>
  <keyword>Contralateral Oblique View</keyword>
  <keyword>Thoracic epidural block</keyword>
  <keyword>Mid thoracic epidural space</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Zoster</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03789955
org study id: 2018-1551
nct id: NCT03789955
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to compare contralateral oblique view with the lateral view
      for fluoroscopic guided mid-thoracic epidural assess.
A thoracic epidural assess (block or catheter insertion) is a widely used intervention to
      reduce pain in patients with postherpetic neuralgia or who underwent chest and upper
      abdominal surgery.

      In order to achieve the correct procedure, accurate access to the thoracic epidural space is
      needed. However, a thoracic epidural assess is a relatively more difficult procedure than
      procedures used in other regions, because the spinous process of the thoracic vertebra is
      longer than that of the lumbar vertebra, and the area through which the needle can approach
      the epidural space is relatively smaller due to an acute angle and larger distance between
      the skin and the epidural space. The midthoracic region (T4-8) is the most difficult area
      when performing this procedure.

      To overcome this issue, a method of approaching the thoracic epidural space through the
      contralateral oblique view (CLO view) has been introduced, however, unlike the cervical or
      lumbar spine, advantages of the CLO view over the lateral view or the optimal angle of the
      CLO view have not yet been studied. Therefore, we planned this study to investigate the
      advantages of the CLO view compared with the lateral view and to determine the optimal angles
      of the CLO view when fluoroscopic guided mid-thoracic epidural assess.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Distance between the tip of epidural needle and the baseline (CLO view - ventral interlaminar line, lateral view - spinolaminar line) at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)
time frame: One day after the procedure
description: Location of the needle tip was defined as being significantly before the baseline (-2), just before the baseline (-1), on the baseline (0), just after the baseline (+1), or significantly after the baseline (+2).
measure: The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)
time frame: One day after the procedure
description: The clarity of the needle tip was subjectively graded as 1 (clearly visualized without ambiguity), 2 (poorly visualized or visualized with effort), or 3 (not visualized).
arm group label: Fluoroscopic-guided TEB
arm group type: Experimental
description: After assessment of the epidural space using the loss of resistance technique with air under fluoroscopic guidance, six fluoroscopic views will be obtained: true anteroposterior, contralateral oblique (CLO) at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral for comparison CLO view with lateral view.
intervention type: Procedure
intervention name: Fluoroscopic-guided TEB
description: When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.
arm group label: Fluoroscopic-guided TEB
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Seong-Soo Choi, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Seong-Soo Choi, MD, PhD
investigator title: Assistant Professor
mesh term: Herpes Zoster
mesh term: Neuralgia
mesh term: Neuralgia, Postherpetic