<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/NCT03308136</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0683</org_study_id>
    <nct_id>NCT03308136</nct_id>
  </id_info>
  <brief_title>The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections</brief_title>
  <official_title>The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei 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>
      Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral&#xD;
      radicular pain. But needle handling during the procedure may cause pain and discomfort to the&#xD;
      patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer&#xD;
      along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In&#xD;
      addition, it can reduce the injection site pain that may occur after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be&#xD;
           performed after receiving the informed consent of the patient.&#xD;
&#xD;
        2. This study is single-blind because it is not possible to blind the practitioner&#xD;
           performing the injection.&#xD;
&#xD;
        3. Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the&#xD;
           muscle anesthesia group (group B) by a random random number table, and the possibilities&#xD;
           for belonging to any group were all the same and can not be artificially controlled by&#xD;
           researchers.&#xD;
&#xD;
        4. After the procedure, a resident who does not know of this study records the patient's&#xD;
           pain and discomfort. and on follow-up visits, post injection site pain is checked.&#xD;
&#xD;
        5. Because of the large difference between the skilled and unskilled patients, the&#xD;
           procedure in this study is performed by only one skilled practitioner&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>
    <intervention_model_description>subcutaneous anesthesia group (group A) muscle anesthesia group (group B)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown.&#xD;
The Outcomes Assessor is not related to the study, and does not know its contents.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural Pain score (NRS)</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>At the next outpatient visit, whether the injection site pain(Yes) or not(No)</measure>
    <time_frame>2 weeks</time_frame>
    <description>At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Lumbar Radiculopathy Due to Spinal Nerve Compression</condition>
  <arm_group>
    <arm_group_label>subcutaneous anesthesia group (group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>muscle anesthesia group (group B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.</intervention_name>
    <description>1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.</description>
    <arm_group_label>subcutaneous anesthesia group (group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.</intervention_name>
    <description>2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.</description>
    <arm_group_label>muscle anesthesia group (group B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Lidocaine</intervention_name>
    <description>1% Lidocaine</description>
    <arm_group_label>muscle anesthesia group (group B)</arm_group_label>
    <arm_group_label>subcutaneous anesthesia group (group A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over&#xD;
        20 years of age are eligible for radiculopathy due to back nerve root compression and&#xD;
        subject to fluoroscopically guided lumbar transforaminal epidural Injection at the&#xD;
        suspected spinal nerveroots level.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood clotting disorder&#xD;
&#xD;
          2. Infection around the site&#xD;
&#xD;
          3. Contrast agent allergy&#xD;
&#xD;
          4. Uncontrolled cardiovascular, cerebrovascular, kidney disease&#xD;
&#xD;
          5. Past history of spinal surgery (ex, spinal fusion)&#xD;
&#xD;
          6. If can not block due to Non-cooperation with subjects (ex, if you can not take the&#xD;
             stomach)&#xD;
&#xD;
          7. Patients taking narcotic analgesics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epidural steroid injection</keyword>
  <keyword>procedural pain</keyword>
  <keyword>local Anesthetic Injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03308136
org study id: 4-2017-0683
nct id: NCT03308136
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral
      radicular pain. But needle handling during the procedure may cause pain and discomfort to the
      patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer
      along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In
      addition, it can reduce the injection site pain that may occur after the procedure.
1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be
           performed after receiving the informed consent of the patient.

        2. This study is single-blind because it is not possible to blind the practitioner
           performing the injection.

        3. Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the
           muscle anesthesia group (group B) by a random random number table, and the possibilities
           for belonging to any group were all the same and can not be artificially controlled by
           researchers.

        4. After the procedure, a resident who does not know of this study records the patient's
           pain and discomfort. and on follow-up visits, post injection site pain is checked.

        5. Because of the large difference between the skilled and unskilled patients, the
           procedure in this study is performed by only one skilled practitioner
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown.
The Outcomes Assessor is not related to the study, and does not know its contents.
measure: Procedural Pain score (NRS)
time frame: Immediately after the procedure
description: Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
measure: At the next outpatient visit, whether the injection site pain(Yes) or not(No)
time frame: 2 weeks
description: At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.
arm group label: subcutaneous anesthesia group (group A)
arm group type: Experimental
arm group label: muscle anesthesia group (group B)
arm group type: Active Comparator
intervention type: Procedure
intervention name: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
description: 1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
arm group label: subcutaneous anesthesia group (group A)
intervention type: Procedure
intervention name: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
description: 2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
arm group label: muscle anesthesia group (group B)
intervention type: Drug
intervention name: 1% Lidocaine
description: 1% Lidocaine
arm group label: muscle anesthesia group (group B)
arm group label: subcutaneous anesthesia group (group A)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Radiculopathy
mesh term: Pain, Procedural
mesh term: Lidocaine
mesh term: Anesthetics, Local
mesh term: Anesthetics
sharing ipd: No