<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/NCT02225054</url>
  </required_header>
  <id_info>
    <org_study_id>DEX-2013</org_study_id>
    <nct_id>NCT02225054</nct_id>
  </id_info>
  <brief_title>The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery</brief_title>
  <acronym>DEX</acronym>
  <official_title>The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Women's College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given&#xD;
      either intravenously or as part of the interscalene nerve block solution, prolongs pain&#xD;
      relief following shoulder surgery compared to local anesthetic solution alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and&#xD;
      Bankart procedure generally allow the patient to go home the same day. However, post-surgical&#xD;
      pain is often severe and it is common to encounter a delay in discharge from the hospital due&#xD;
      to difficulty in pain control.&#xD;
&#xD;
      Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that&#xD;
      included a significant reduction in acute pain and analgesic requirements, prolonged time to&#xD;
      first analgesic request, decreased incidence of nausea, as well as earlier hospital&#xD;
      discharge. Previous studies have attempted to prolong the duration of the analgesia of&#xD;
      interscalene block by administering additional drugs to the local anesthetics but these&#xD;
      studies have had varying degrees of success. Dexmedetomidine has recently been considered as&#xD;
      a potentially useful drug in prolonging nerve block analgesia. Various modes of&#xD;
      administration of Dexmedetomidine have demonstrated a consistent effect on the duration of&#xD;
      analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and&#xD;
      peripheral nerve blocks. When combined with local anesthetics in intravenous regional&#xD;
      anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal&#xD;
      studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable&#xD;
      of prolonging the duration of analgesia of peripheral nerve blocks.&#xD;
&#xD;
      The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This&#xD;
      trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in&#xD;
      interscalene brachial plexus block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of interscalene nerve block.</measure>
    <time_frame>Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Cumulative opioid consumption at 24 hours postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>Total use of opioids from the period of intra-operative to 2 weeks post-operative</time_frame>
    <description>The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Nerve Pain</condition>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Ropivacaine,Normal Saline,Saline Bolus</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine,Dexmedetomidine,Saline Bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine,Saline,Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction</description>
    <arm_group_label>Ropivacaine,Dexmedetomidine,Saline Bolus</arm_group_label>
    <arm_group_label>Ropivacaine,Saline,Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>15 ml 0.5%</description>
    <arm_group_label>Ropivacaine,Dexmedetomidine,Saline Bolus</arm_group_label>
    <arm_group_label>Ropivacaine,Normal Saline,Saline Bolus</arm_group_label>
    <arm_group_label>Ropivacaine,Saline,Dexmedetomidine</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>1 mL 0.9%</description>
    <arm_group_label>Ropivacaine,Dexmedetomidine,Saline Bolus</arm_group_label>
    <arm_group_label>Ropivacaine,Normal Saline,Saline Bolus</arm_group_label>
    <arm_group_label>Ropivacaine,Saline,Dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral surgical shoulder procedures under general anesthetic&#xD;
&#xD;
          -  English speaking patients&#xD;
&#xD;
          -  ASA I-III patients&#xD;
&#xD;
          -  BMI &lt;38 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  proximal clavicular surgery&#xD;
&#xD;
          -  preexisting neurological deficits or peripheral neuropathy&#xD;
&#xD;
          -  known coronary heart disease, congestive heart failure, cardiomyopathies, or&#xD;
             arrhythmias&#xD;
&#xD;
          -  known cerebrovascular disease&#xD;
&#xD;
          -  baseline heart rate &lt;60 beats per minute or baseline systolic blood pressure &lt;100 mm&#xD;
             Hg&#xD;
&#xD;
          -  medications that reduce heart rate (as beta-blockers, calcium blockers) known liver&#xD;
             dysfunction or existing diseases known to cause hepatic or renal impairment&#xD;
&#xD;
          -  severe bronchopulmonary disease&#xD;
&#xD;
          -  local infection&#xD;
&#xD;
          -  contra-indication to regional anesthesia (bleeding, coagulopathy)&#xD;
&#xD;
          -  chronic pain disorders&#xD;
&#xD;
          -  current use of over 30mg oxycodone or equivalent per day&#xD;
&#xD;
          -  contraindication to a component of multimodal analgesia&#xD;
&#xD;
          -  allergy to local anesthetics or dexmedetomidine&#xD;
&#xD;
          -  history of significant psychiatric conditions that may affect patient assessment&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard M. Brull, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto, Women's College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>duration of analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Ropivacaine</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/NCT02225054
org study id: DEX-2013
nct id: NCT02225054
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given
      either intravenously or as part of the interscalene nerve block solution, prolongs pain
      relief following shoulder surgery compared to local anesthetic solution alone.
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and
      Bankart procedure generally allow the patient to go home the same day. However, post-surgical
      pain is often severe and it is common to encounter a delay in discharge from the hospital due
      to difficulty in pain control.

      Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that
      included a significant reduction in acute pain and analgesic requirements, prolonged time to
      first analgesic request, decreased incidence of nausea, as well as earlier hospital
      discharge. Previous studies have attempted to prolong the duration of the analgesia of
      interscalene block by administering additional drugs to the local anesthetics but these
      studies have had varying degrees of success. Dexmedetomidine has recently been considered as
      a potentially useful drug in prolonging nerve block analgesia. Various modes of
      administration of Dexmedetomidine have demonstrated a consistent effect on the duration of
      analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and
      peripheral nerve blocks. When combined with local anesthetics in intravenous regional
      anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal
      studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable
      of prolonging the duration of analgesia of peripheral nerve blocks.

      The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This
      trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in
      interscalene brachial plexus block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Duration of interscalene nerve block.
time frame: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
measure: Opioid consumption
time frame: Cumulative opioid consumption at 24 hours postoperatively
measure: Opioid Consumption
time frame: Total use of opioids from the period of intra-operative to 2 weeks post-operative
description: The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.
arm group label: Ropivacaine,Normal Saline,Saline Bolus
arm group type: Placebo Comparator
description: Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus
arm group label: Ropivacaine,Dexmedetomidine,Saline Bolus
arm group type: Experimental
description: Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus
arm group label: Ropivacaine,Saline,Dexmedetomidine
arm group type: Active Comparator
description: Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes
intervention type: Drug
intervention name: Dexmedetomidine
description: 0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction
arm group label: Ropivacaine,Dexmedetomidine,Saline Bolus
arm group label: Ropivacaine,Saline,Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Ropivacaine
description: 15 ml 0.5%
arm group label: Ropivacaine,Dexmedetomidine,Saline Bolus
arm group label: Ropivacaine,Normal Saline,Saline Bolus
arm group label: Ropivacaine,Saline,Dexmedetomidine
other name: Naropin
intervention type: Drug
intervention name: Normal Saline
description: 1 mL 0.9%
arm group label: Ropivacaine,Dexmedetomidine,Saline Bolus
arm group label: Ropivacaine,Normal Saline,Saline Bolus
arm group label: Ropivacaine,Saline,Dexmedetomidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Richard M. Brull, MD, FRCPC
role: Principal Investigator
affiliation: University of Toronto, Women's College Hospital
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Neuralgia
mesh term: Dexmedetomidine
mesh term: Ropivacaine