<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/NCT03040648</url>
  </required_header>
  <id_info>
    <org_study_id>KNUH 2016-05-039-001</org_study_id>
    <nct_id>NCT03040648</nct_id>
  </id_info>
  <brief_title>Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block</brief_title>
  <official_title>Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block: a Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat&#xD;
      spinal radicular pain. However, inadvertent intravascular injection can lead to severe&#xD;
      neurologic complications. Digital subtraction angiography (DSA) during epidural block might&#xD;
      increase the detection rate of intravascular penetration, compared to real-time fluoroscopy&#xD;
      (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and&#xD;
      participants and the high cost of the new and upgraded fluoroscopic equipment. In this study,&#xD;
      it was designed to compare DSA and RTF for detection of intravascular penetration in the same&#xD;
      participant who underwent cervical TFEB.&#xD;
&#xD;
      The investigators prospectively examined the participants who received cervical TFEB. The&#xD;
      needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media&#xD;
      was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic&#xD;
      contrast media was injected at the rate of 0.5 ml/sec under DSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of intravascular injection</measure>
    <time_frame>4 seconds after injection of contrast media</time_frame>
    <description>The incidence of intravascular injection during cervical transforaminal block</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Diagnostic Imaging</condition>
  <arm_group>
    <arm_group_label>cervical TFEB under DSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cervical TFEB was performed under DSA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TFEB under RTF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cervical TFEB was performed under RTF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DSA</intervention_name>
    <description>DSA was used for detection of intravascular injection</description>
    <arm_group_label>cervical TFEB under DSA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RTF</intervention_name>
    <description>RTF was used for detection of intravascular injection</description>
    <arm_group_label>TFEB under RTF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants with radiating pain from spinal stenosis and herniated nucleus pulposus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, allergic to contrast media, participants refusal, and participants with&#xD;
             persistent contraindication to nerve block such as coagulopathy and infection of the&#xD;
             injection site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saeyoung Kim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Younghoon Jeon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03040648
org study id: KNUH 2016-05-039-001
nct id: NCT03040648
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat
      spinal radicular pain. However, inadvertent intravascular injection can lead to severe
      neurologic complications. Digital subtraction angiography (DSA) during epidural block might
      increase the detection rate of intravascular penetration, compared to real-time fluoroscopy
      (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and
      participants and the high cost of the new and upgraded fluoroscopic equipment. In this study,
      it was designed to compare DSA and RTF for detection of intravascular penetration in the same
      participant who underwent cervical TFEB.

      The investigators prospectively examined the participants who received cervical TFEB. The
      needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media
      was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic
      contrast media was injected at the rate of 0.5 ml/sec under DSA.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The incidence of intravascular injection
time frame: 4 seconds after injection of contrast media
description: The incidence of intravascular injection during cervical transforaminal block
arm group label: cervical TFEB under DSA
arm group type: Experimental
description: cervical TFEB was performed under DSA
arm group label: TFEB under RTF
arm group type: Active Comparator
description: cervical TFEB was performed under RTF
intervention type: Device
intervention name: DSA
description: DSA was used for detection of intravascular injection
arm group label: cervical TFEB under DSA
intervention type: Device
intervention name: RTF
description: RTF was used for detection of intravascular injection
arm group label: TFEB under RTF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saeyoung Kim, MD
role: Study Chair
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Younghoon Jeon
investigator title: Professor
sharing ipd: No