<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/NCT01730573</url>
  </required_header>
  <id_info>
    <org_study_id>102994</org_study_id>
    <nct_id>NCT01730573</nct_id>
  </id_info>
  <brief_title>Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair</brief_title>
  <official_title>A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      Primary objective of this study is to prospectively compare and evaluate efficacy as well as&#xD;
      note side effects of the interscalene block and combined suprascapular and axillary nerve&#xD;
      block for ambulatory arthroscopic rotator cuff repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients having elective arthroscopic rotator cuff repair will be randomized to one of the&#xD;
      two groups.&#xD;
&#xD;
      Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator&#xD;
      aided) followed by a general anesthesia.&#xD;
&#xD;
      Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided&#xD;
      and nerve stimulator aided) followed by a general anesthesia.&#xD;
&#xD;
      Performance time, quality and efficacy as well as any side-effects of the blocks will be&#xD;
      evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning,&#xD;
      opioid usage and patient satisfaction.&#xD;
&#xD;
      Primary hypothesis:&#xD;
&#xD;
      • Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as&#xD;
      compared to interscalene block for arthroscopic rotator cuff repair.&#xD;
&#xD;
      Secondary hypothesis&#xD;
&#xD;
      • Interscalene block is associated with more side effects and complications as compared to&#xD;
      suprascapular nerve block and axillary nerve block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic Efficacy</measure>
    <time_frame>one year</time_frame>
    <description>Visual Analogue scores for pain will be analyzed using chi-squared test. Interscalene block (ISB) of the brachial plexus has been demonstrated to be one of the most effective analgesic modality during arthroscopic shoulder surgery. However, despite its (ISB) time-tested record of relative safety, ISB is associated with some complications. These could be central nervous system, respiratory and cardiovascular complications. These side effects and complications are based upon the anatomy of the brachial plexus at this level.Recently, suprascapular and axillary nerve blocks have been used to control postoperative shoulder pain. The study will try to find out whether combined supra scapular and axillary nerve blocks are as effective in pain control as compared to inter scalene block.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>1 year</time_frame>
    <description>The study will try to find out whether combined supra scapular and axillary nerve blocks are associated with less side effects as compared to inter scalene block.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Disorder of Rotator Cuff</condition>
  <arm_group>
    <arm_group_label>Interscalene block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suprascapular and Axillary nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>interscalene block</intervention_name>
    <description>This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.</description>
    <arm_group_label>Interscalene block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprascapular and Axillary nerve block</intervention_name>
    <description>This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.</description>
    <arm_group_label>Suprascapular and Axillary nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective shoulder arthroscopic rotator cuff repair&#xD;
&#xD;
          -  ASA I - III (American Society of Anaesthesia Classification)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA IV or higher ( American Society of Anaesthesia Classification)&#xD;
&#xD;
          -  Obesity: BMI &gt;35&#xD;
&#xD;
          -  Narcotic Abuse/ Drug dependency&#xD;
&#xD;
          -  Major Neurologic deficits&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Infection in the site of the puncture&#xD;
&#xD;
          -  Mental impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalini Dhir, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Health Care</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 11, 2017</last_update_submitted>
  <last_update_submitted_qc>February 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Shalini Dhir</investigator_full_name>
    <investigator_title>Associate Professor, Department of Anaesthesia</investigator_title>
  </responsible_party>
  <keyword>interscalene</keyword>
  <keyword>suprascapular</keyword>
  <keyword>axillary</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 29, 2017</submitted>
    <returned>April 2, 2018</returned>
  </pending_results>
  <!-- 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/NCT01730573
org study id: 102994
nct id: NCT01730573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary objective of this study is to prospectively compare and evaluate efficacy as well as
      note side effects of the interscalene block and combined suprascapular and axillary nerve
      block for ambulatory arthroscopic rotator cuff repair.
Patients having elective arthroscopic rotator cuff repair will be randomized to one of the
      two groups.

      Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator
      aided) followed by a general anesthesia.

      Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided
      and nerve stimulator aided) followed by a general anesthesia.

      Performance time, quality and efficacy as well as any side-effects of the blocks will be
      evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning,
      opioid usage and patient satisfaction.

      Primary hypothesis:

      • Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as
      compared to interscalene block for arthroscopic rotator cuff repair.

      Secondary hypothesis

      • Interscalene block is associated with more side effects and complications as compared to
      suprascapular nerve block and axillary nerve block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Analgesic Efficacy
time frame: one year
description: Visual Analogue scores for pain will be analyzed using chi-squared test. Interscalene block (ISB) of the brachial plexus has been demonstrated to be one of the most effective analgesic modality during arthroscopic shoulder surgery. However, despite its (ISB) time-tested record of relative safety, ISB is associated with some complications. These could be central nervous system, respiratory and cardiovascular complications. These side effects and complications are based upon the anatomy of the brachial plexus at this level.Recently, suprascapular and axillary nerve blocks have been used to control postoperative shoulder pain. The study will try to find out whether combined supra scapular and axillary nerve blocks are as effective in pain control as compared to inter scalene block.
measure: Side effects
time frame: 1 year
description: The study will try to find out whether combined supra scapular and axillary nerve blocks are associated with less side effects as compared to inter scalene block.
measure: Patient satisfaction
time frame: 1 year
arm group label: Interscalene block
arm group type: Active Comparator
description: This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
arm group label: Suprascapular and Axillary nerve block
arm group type: Active Comparator
description: This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
intervention type: Procedure
intervention name: interscalene block
description: This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
arm group label: Interscalene block
intervention type: Procedure
intervention name: Suprascapular and Axillary nerve block
description: This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
arm group label: Suprascapular and Axillary nerve block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shalini Dhir, MD, FRCPC
role: Principal Investigator
affiliation: Western University, Canada
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Shalini Dhir
investigator title: Associate Professor, Department of Anaesthesia
sharing ipd: No
submitted: August 29, 2017
returned: April 2, 2018