<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/NCT02253784</url>
  </required_header>
  <id_info>
    <org_study_id>14-XX-HYMC</org_study_id>
    <nct_id>NCT02253784</nct_id>
  </id_info>
  <brief_title>Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the&#xD;
      duration of a block in total knee arthroplasty. The aim of this study is to determine whether&#xD;
      this is a systemic or local effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy Perineural DxaM</measure>
    <time_frame>One day</time_frame>
    <description>Duration of motor and sensory block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of Systemic DxaM</measure>
    <time_frame>One day</time_frame>
    <description>Duration of motor and sensory block</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Analgesia</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Group I (ISB-P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (ISB-S)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III (ISB-C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four nerve blocks without dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Group I (ISB-P)</arm_group_label>
    <arm_group_label>Group II (ISB-S)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <arm_group_label>Group I (ISB-P)</arm_group_label>
    <arm_group_label>Group II (ISB-S)</arm_group_label>
    <arm_group_label>Group III (ISB-C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-surgical total knee arthroplasty patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin infection near block site&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Proven opioid dependency&#xD;
&#xD;
          -  Coagulopathy&#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_official>
    <last_name>Anatoly Stav, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <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>October 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <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/NCT02253784
org study id: 14-XX-HYMC
nct id: NCT02253784
lead sponsor: 
has dmc: Yes
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the
      duration of a block in total knee arthroplasty. The aim of this study is to determine whether
      this is a systemic or local effect.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy Perineural DxaM
time frame: One day
description: Duration of motor and sensory block
measure: Efficacy of Systemic DxaM
time frame: One day
description: Duration of motor and sensory block
arm group label: Group I (ISB-P)
arm group type: Active Comparator
description: Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml
arm group label: Group II (ISB-S)
arm group type: Active Comparator
description: Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml
arm group label: Group III (ISB-C)
arm group type: Active Comparator
description: Four nerve blocks without dexamethasone
intervention type: Drug
intervention name: Dexamethasone
arm group label: Group I (ISB-P)
arm group label: Group II (ISB-S)
intervention type: Drug
intervention name: Bupivacaine
arm group label: Group I (ISB-P)
arm group label: Group II (ISB-S)
arm group label: Group III (ISB-C)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anatoly Stav, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Bupivacaine