<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/NCT04467398</url>
  </required_header>
  <id_info>
    <org_study_id>2004-207-1120</org_study_id>
    <nct_id>NCT04467398</nct_id>
  </id_info>
  <brief_title>Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks</brief_title>
  <official_title>Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks and Impact of Needle Types to the IV Uptake: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the incidence of intravascular injection during&#xD;
      trigeminal nerve blocks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1&#xD;
      ratio to tuohy needle group or quincke needle group after being informed about the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>IV uptake prevalence (%)</measure>
    <time_frame>During the procedure</time_frame>
    <description>The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in incidence of intravascular injection</measure>
    <time_frame>During the procedure</time_frame>
    <description>Difference in incidence of intravascular injection according to needle type by DSA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total incidence of blood aspiration</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total incidence of blood aspiration by regurgitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total incidence of intravascular injection</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total incidence of intravascular injection under non-DSA technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.</measure>
    <time_frame>During the procedure</time_frame>
    <description>The depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of needle adjustment.</measure>
    <time_frame>During the procedure</time_frame>
    <description>The number of needle adjustment due to the intravascular uptake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of local anesthetics for skin anesthesia.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total volume of local anesthetics for skin anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for the procedure.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Time for the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of radiation exposure for the procedure.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total amount of radiation exposure for the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laterality</measure>
    <time_frame>During the procedure</time_frame>
    <description>The difference in incidence by the lateriality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final pattern of the fluoroscopic image</measure>
    <time_frame>During the procedure</time_frame>
    <description>The quality of the image(3: excellent, 2: acceptable, 1: not relevant)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-procedure pain</measure>
    <time_frame>Within 1 hour after the procedure.</time_frame>
    <description>NRS pain score after the procedure in recovery room</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difficulty of the procedure</measure>
    <time_frame>Within 1 hour after the procedure.</time_frame>
    <description>The difficulty grade by the practitioner(5:very easy, 4: relatively easy, 3:so so, 4:somewhat difficult, 1:very difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference in incidence of blood aspiration</measure>
    <time_frame>During the procedure.</time_frame>
    <description>Difference in incidence of intravascular injection according to needle type by regurgitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference in incidence of intravascular injection.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Difference in incidence of intravascular injection according to needle type by non-DSA technique.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Trigeminal Neuralgia</condition>
  <condition>Facial Pain</condition>
  <condition>Postherpetic Neuralgia</condition>
  <condition>Cluster Headache</condition>
  <arm_group>
    <arm_group_label>Tuohy needle group</arm_group_label>
    <description>The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quincke needle group</arm_group_label>
    <description>The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trigeminal nerve block</intervention_name>
    <description>Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.</description>
    <arm_group_label>Quincke needle group</arm_group_label>
    <arm_group_label>Tuohy needle group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who scheduled to undergo trigeminal nerve block because of:&#xD;
&#xD;
          1. Trigeminal neuralgia/neuropathy&#xD;
&#xD;
          2. Postherpetic trigeminal neuralgia&#xD;
&#xD;
          3. Atypical facial pain&#xD;
&#xD;
          4. Cluster headache&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients who scheduled to undergo trigeminal nerve block due to the facial pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Local or systemic infection&#xD;
&#xD;
          -  Allergy to injectate&#xD;
&#xD;
          -  Anatomical deformation of the skull&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jee Youn Moon, MD, PhD</last_name>
    <phone>82220722952</phone>
    <email>jymoon0901@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yongjae Yoo, MD, PhD</last_name>
    <phone>82220722952</phone>
    <email>rkdarkef@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jee Youn Moon, M.D.</last_name>
      <phone>82-10-5299-2036</phone>
      <email>jymoon0901@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jee Youn Moon, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University</investigator_affiliation>
    <investigator_full_name>Jeeyoun Moon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigeminal Neuralgia</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Cluster Headache</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</mesh_term>
    <mesh_term>Headache</mesh_term>
    <mesh_term>Facial Pain</mesh_term>
  </condition_browse>
  <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/NCT04467398
org study id: 2004-207-1120
nct id: NCT04467398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the incidence of intravascular injection during
      trigeminal nerve blocks.
The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1
      ratio to tuohy needle group or quincke needle group after being informed about the study.
observational model: Case-Control
time perspective: Prospective
measure: IV uptake prevalence (%)
time frame: During the procedure
description: The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).
measure: Difference in incidence of intravascular injection
time frame: During the procedure
description: Difference in incidence of intravascular injection according to needle type by DSA.
measure: Total incidence of blood aspiration
time frame: During the procedure
description: Total incidence of blood aspiration by regurgitation.
measure: Total incidence of intravascular injection
time frame: During the procedure
description: Total incidence of intravascular injection under non-DSA technique.
measure: The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.
time frame: During the procedure
description: The depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.
measure: The number of needle adjustment.
time frame: During the procedure
description: The number of needle adjustment due to the intravascular uptake.
measure: Total volume of local anesthetics for skin anesthesia.
time frame: During the procedure
description: Total volume of local anesthetics for skin anesthesia.
measure: Time for the procedure.
time frame: During the procedure
description: Time for the procedure.
measure: Total amount of radiation exposure for the procedure.
time frame: During the procedure
description: Total amount of radiation exposure for the procedure.
measure: Laterality
time frame: During the procedure
description: The difference in incidence by the lateriality.
measure: Final pattern of the fluoroscopic image
time frame: During the procedure
description: The quality of the image(3: excellent, 2: acceptable, 1: not relevant)
measure: Post-procedure pain
time frame: Within 1 hour after the procedure.
description: NRS pain score after the procedure in recovery room
measure: The difficulty of the procedure
time frame: Within 1 hour after the procedure.
description: The difficulty grade by the practitioner(5:very easy, 4: relatively easy, 3:so so, 4:somewhat difficult, 1:very difficult)
measure: The difference in incidence of blood aspiration
time frame: During the procedure.
description: Difference in incidence of intravascular injection according to needle type by regurgitation.
measure: The difference in incidence of intravascular injection.
time frame: During the procedure
description: Difference in incidence of intravascular injection according to needle type by non-DSA technique.
arm group label: Tuohy needle group
description: The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.
arm group label: Quincke needle group
description: The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.
intervention type: Procedure
intervention name: trigeminal nerve block
description: Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.
arm group label: Quincke needle group
arm group label: Tuohy needle group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jee Youn Moon, MD, PhD
phone: 82220722952
email: jymoon0901@gmail.com
last name: Yongjae Yoo, MD, PhD
phone: 82220722952
email: rkdarkef@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University
investigator full name: Jeeyoun Moon
investigator title: Associate Professor
mesh term: Trigeminal Neuralgia
mesh term: Neuralgia
mesh term: Cluster Headache
mesh term: Neuralgia, Postherpetic
mesh term: Headache
mesh term: Facial Pain
sharing ipd: No