<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/NCT03286946</url>
  </required_header>
  <id_info>
    <org_study_id>2016-09-009</org_study_id>
    <nct_id>NCT03286946</nct_id>
  </id_info>
  <brief_title>Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.</brief_title>
  <official_title>The Difference of Intravascular Injection Rate During Cervical Transforaminal Epidural Block Using Blunt-type Block Needle Compared to Sharp-type Block Needle.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the incidence of intravascular injection during cervical transforaminal&#xD;
      epidural block using blunt needle, compared to the sharp needle. The investigators will&#xD;
      performed cervical transforaminal epidural block using blunt-type block needle in half of&#xD;
      participants or sharp-type block needle in the other half.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical transforaminal epidural block is an effective treatment option of radiating pain.&#xD;
      There are potential risks associated with transforaminal epidural block such as infection,&#xD;
      dural puncture, bleeding, and intravascular injection. Although the risk is low,&#xD;
      intravascular injection should be carefully monitored because intravascular injection of&#xD;
      particulate steroids can cause fatal neurologic deficits such as spinal infarction and&#xD;
      cerebral infarction.&#xD;
&#xD;
      The incidence of intravascular injection during transforaminal epidural block with real time&#xD;
      fluoroscopy guidance depends on spinal level. The previous studies using real time&#xD;
      fluoroscopy demonstrated that the incidence of intravascular injection of cervical&#xD;
      transforaminal epidural block is higher than that of lumbosacral transforaminal epidural&#xD;
      block.&#xD;
&#xD;
      In this study, therefore, the investigators investigate the incidence of intravascular&#xD;
      injection during cervical transforaminal epidural block using blunt needle, compared to the&#xD;
      sharp needle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2016</start_date>
  <completion_date type="Actual">July 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intravascular injection</measure>
    <time_frame>During procedure</time_frame>
    <description>Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Needling time</measure>
    <time_frame>During procedure</time_frame>
    <description>Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Pain</condition>
  <condition>Radicular; Neuropathic, Cervical</condition>
  <arm_group>
    <arm_group_label>Blunt-type block needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>block with Blunt-type block needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sharp-type block needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>block with Sharp-type block needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>block with Blunt-type block needle.</intervention_name>
    <description>Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.</description>
    <arm_group_label>Blunt-type block needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>block with sharp-type block needle.</intervention_name>
    <description>Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.</description>
    <arm_group_label>Sharp-type block needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with radiating pain from cervical spinal stenosis and herniated nucleus&#xD;
             pulposus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, allergic to contrast media, patient refusal, and patients with persistent&#xD;
             contraindication to nerve block such as coagulopathy and infection of the injection&#xD;
             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>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 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>Saeyoung Kim, MD, PhD</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>Radiculopathy</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/NCT03286946
org study id: 2016-09-009
nct id: NCT03286946
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the incidence of intravascular injection during cervical transforaminal
      epidural block using blunt needle, compared to the sharp needle. The investigators will
      performed cervical transforaminal epidural block using blunt-type block needle in half of
      participants or sharp-type block needle in the other half.
Cervical transforaminal epidural block is an effective treatment option of radiating pain.
      There are potential risks associated with transforaminal epidural block such as infection,
      dural puncture, bleeding, and intravascular injection. Although the risk is low,
      intravascular injection should be carefully monitored because intravascular injection of
      particulate steroids can cause fatal neurologic deficits such as spinal infarction and
      cerebral infarction.

      The incidence of intravascular injection during transforaminal epidural block with real time
      fluoroscopy guidance depends on spinal level. The previous studies using real time
      fluoroscopy demonstrated that the incidence of intravascular injection of cervical
      transforaminal epidural block is higher than that of lumbosacral transforaminal epidural
      block.

      In this study, therefore, the investigators investigate the incidence of intravascular
      injection during cervical transforaminal epidural block using blunt needle, compared to the
      sharp needle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Intravascular injection
time frame: During procedure
description: Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.
measure: Needling time
time frame: During procedure
description: Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.
arm group label: Blunt-type block needle
arm group type: Experimental
description: block with Blunt-type block needle.
arm group label: Sharp-type block needle
arm group type: Active Comparator
description: block with Sharp-type block needle.
intervention type: Procedure
intervention name: block with Blunt-type block needle.
description: Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
arm group label: Blunt-type block needle
intervention type: Procedure
intervention name: block with sharp-type block needle.
description: Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
arm group label: Sharp-type block needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Saeyoung Kim, MD, PhD
investigator title: Associate professor
mesh term: Radiculopathy