<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/NCT01684774</url>
  </required_header>
  <id_info>
    <org_study_id>0070-12-HYMC</org_study_id>
    <nct_id>NCT01684774</nct_id>
  </id_info>
  <brief_title>Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic&#xD;
      landmark-guided (ALG) ankle block to determine which of these procedures is better in&#xD;
      surgical anesthesia and in postoperative pain relief.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Surgical Anesthesia Sufficient</measure>
    <time_frame>Thirty minutes</time_frame>
    <description>Sufficiency of surgical anesthesia will be determined by the presence of a complete sensory or motor block. If general anesthesia needs to be added to achieve operative analgesia, the surgical block will not be deemed sufficient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative Pain Relief</measure>
    <time_frame>Twenty-four hours</time_frame>
    <description>Intensity of post-operative pain will be measured by a numerical scale from 0-10 by the patient</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>I. USG</arm_group_label>
    <description>Patients receiving Ultrasound-guided Ankle Block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>II. ALG</arm_group_label>
    <description>Patients receiving Anatomic Landmark-guided Ankle Block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <arm_group_label>I. USG</arm_group_label>
    <arm_group_label>II. ALG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult ASA I-III (American Society of Anesthesiologists classification) patients undergoing&#xD;
        orthopedic foot operation with osteotomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing orthopedic foot operation with osteotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin infection near block injection site&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Coagulopathy with INR &gt;1.4.&#xD;
&#xD;
          -  Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Leonid Reytman, MD</last_name>
    <phone>972-54-4226640</phone>
    <email>lrey@netvision.net.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT01684774
org study id: 0070-12-HYMC
nct id: NCT01684774
lead sponsor: 
has dmc: No
The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic
      landmark-guided (ALG) ankle block to determine which of these procedures is better in
      surgical anesthesia and in postoperative pain relief.
observational model: Case-Control
time perspective: Prospective
measure: Surgical Anesthesia Sufficient
time frame: Thirty minutes
description: Sufficiency of surgical anesthesia will be determined by the presence of a complete sensory or motor block. If general anesthesia needs to be added to achieve operative analgesia, the surgical block will not be deemed sufficient.
measure: Post-operative Pain Relief
time frame: Twenty-four hours
description: Intensity of post-operative pain will be measured by a numerical scale from 0-10 by the patient
arm group label: I. USG
description: Patients receiving Ultrasound-guided Ankle Block
arm group label: II. ALG
description: Patients receiving Anatomic Landmark-guided Ankle Block
intervention type: Drug
intervention name: Bupivacaine
arm group label: I. USG
arm group label: II. ALG
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leonid Reytman, MD
phone: 972-54-4226640
email: lrey@netvision.net.il
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Bupivacaine