<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/NCT04445480</url>
  </required_header>
  <id_info>
    <org_study_id>SI198/2019</org_study_id>
    <nct_id>NCT04445480</nct_id>
  </id_info>
  <brief_title>Popliteal Block for Lower Limb Angioplasty</brief_title>
  <official_title>The Benefit of Popliteal Sciatic Nerve Block for Lower Limb Angioplasty in Critical Limb Ischemia: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol 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>
      Endovascular revascularization is an effective procedure in treatment of chronic critical&#xD;
      limb ischemia. The less invasive procedure in high risk patients produce the benefit to the&#xD;
      patients. However, some of the patients cannot tolerate local anaesthesia. These patients&#xD;
      need sedation or even general anaesthesia, which increase unnecessary risk to the patients.&#xD;
      This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal&#xD;
      block compare to sedation in critical limb patients undergoing angioplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of general anaesthesia</measure>
    <time_frame>Five hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical pain rating scale during procedure</measure>
    <time_frame>Five hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Angioplasty</condition>
  <condition>Anaesthesia and Analgesia</condition>
  <arm_group>
    <arm_group_label>Popliteal block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Popliteal block</intervention_name>
    <description>Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.</description>
    <arm_group_label>Popliteal block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 20 year-old with chronic ischemic limb pain&#xD;
&#xD;
          -  Scheduled for peripheral angioplasty under monitor anaesthesia care&#xD;
&#xD;
          -  Expected timing of procedure not more than 3 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 21&#xD;
&#xD;
          -  Cannot cooperate with the staff&#xD;
&#xD;
          -  Having pain in other areas or both legs&#xD;
&#xD;
          -  Contraindicate for nerve block&#xD;
&#xD;
          -  Allergy to local anesthetic drugs or sedative drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anesthesiology department, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>popliteal block</keyword>
  <keyword>chronic limb ischemia</keyword>
  <!-- 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/NCT04445480
org study id: SI198/2019
nct id: NCT04445480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endovascular revascularization is an effective procedure in treatment of chronic critical
      limb ischemia. The less invasive procedure in high risk patients produce the benefit to the
      patients. However, some of the patients cannot tolerate local anaesthesia. These patients
      need sedation or even general anaesthesia, which increase unnecessary risk to the patients.
      This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal
      block compare to sedation in critical limb patients undergoing angioplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of general anaesthesia
time frame: Five hours
measure: Numerical pain rating scale during procedure
time frame: Five hours
arm group label: Popliteal block group
arm group type: Experimental
arm group label: Control group
arm group type: Active Comparator
intervention type: Procedure
intervention name: Popliteal block
description: Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.
arm group label: Popliteal block group
intervention type: Other
intervention name: Control
description: Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.
arm group label: Control group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Sponsor