<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/NCT03805906</url>
  </required_header>
  <id_info>
    <org_study_id>2018-19-061-H</org_study_id>
    <nct_id>NCT03805906</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided L5 Dorsal Ramus Block</brief_title>
  <acronym>USGL5DR</acronym>
  <official_title>Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kelowna General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montreal General Hospital</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>
      This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients&#xD;
      suffering from chronic low back pain. Because physical examination and medical imaging have&#xD;
      limited value in determining the source of pain, diagnostic blocks play an important role in&#xD;
      the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to&#xD;
      diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly&#xD;
      implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays,&#xD;
      is currently the standard imaging modality used to perform this block. Recently, ultrasound&#xD;
      guidance has seen increasing use because of its greater accessibility and lack of ionizing&#xD;
      radiation. Although USG has been shown to provide a high level of accuracy at other levels,&#xD;
      the greater anatomical complexity found at the L5-S1 has hindered the development of a&#xD;
      satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic&#xD;
      control to examine the accuracy of a novel ultrasound-guided approach to this block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Block accuracy</measure>
    <time_frame>Immediately post-injection</time_frame>
    <description>contrast distribution</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance time</measure>
    <time_frame>Perioperative</time_frame>
    <description>Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needle passes</measure>
    <time_frame>Procedure</time_frame>
    <description>Number of needle passes required to perform block</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain, Back</condition>
  <arm_group>
    <arm_group_label>Primary group</arm_group_label>
    <description>Ultrasound-Guided L5 Dorsal ramus block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>L5 Dorsal ramus block</intervention_name>
    <description>Ultrasound-guided L5 dorsal ramus block</description>
    <arm_group_label>Primary group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Any consenting patient over 18 years of age with axial low back pain who requires a&#xD;
        diagnostic L5 dorsal ramus block.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Iodine or lidocaine allergy,&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented&#xD;
             bleeding disorder)&#xD;
&#xD;
          -  Inability to visualize lumbosacral anatomy during an ultrasound pre- scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kelowna General Hospital</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montreal General Hospital</investigator_affiliation>
    <investigator_full_name>Roderick Finlayson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back 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/NCT03805906
org study id: 2018-19-061-H
nct id: NCT03805906
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.
The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients
      suffering from chronic low back pain. Because physical examination and medical imaging have
      limited value in determining the source of pain, diagnostic blocks play an important role in
      the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to
      diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly
      implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays,
      is currently the standard imaging modality used to perform this block. Recently, ultrasound
      guidance has seen increasing use because of its greater accessibility and lack of ionizing
      radiation. Although USG has been shown to provide a high level of accuracy at other levels,
      the greater anatomical complexity found at the L5-S1 has hindered the development of a
      satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic
      control to examine the accuracy of a novel ultrasound-guided approach to this block.
observational model: Cohort
time perspective: Prospective
measure: Block accuracy
time frame: Immediately post-injection
description: contrast distribution
measure: Performance time
time frame: Perioperative
description: Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
measure: Number of needle passes
time frame: Procedure
description: Number of needle passes required to perform block
arm group label: Primary group
description: Ultrasound-Guided L5 Dorsal ramus block
intervention type: Procedure
intervention name: L5 Dorsal ramus block
description: Ultrasound-guided L5 dorsal ramus block
arm group label: Primary group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Montreal General Hospital
investigator full name: Roderick Finlayson
investigator title: Professor
mesh term: Back Pain
sharing ipd: No