<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/NCT03277326</url>
  </required_header>
  <id_info>
    <org_study_id>2017/2459</org_study_id>
    <nct_id>NCT03277326</nct_id>
  </id_info>
  <brief_title>Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries</brief_title>
  <official_title>Randomised, Controlled Trial Comparing Interscalene Versus Anterior and Posterior Approaches of Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changi General Hospital</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>
      To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung&#xD;
      function and analgesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries.&#xD;
      However, it is associated with several side effects, in particular, a high incidence of&#xD;
      phrenic nerve blockade.&#xD;
&#xD;
      The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has&#xD;
      a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches&#xD;
      for the suprascapular nerve block, anterior and posterior. The anterior approach may still&#xD;
      result in some degree of impairment of lung function.&#xD;
&#xD;
      The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB.&#xD;
      Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">July 7, 2018</completion_date>
  <primary_completion_date type="Actual">June 11, 2018</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>2 years</time_frame>
    <description>To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic effects and complications</measure>
    <time_frame>2 years</time_frame>
    <description>Analgesic effect (pain scores, opioid consumption, opioid related side effects), degree of motor blockade and incidence of adverse effects of blocks (Horner's syndrome, hoarseness of voice)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Arthroscopic Shoulder Surgery</condition>
  <condition>Interscalene Block</condition>
  <condition>Suprascapular Nerve Block</condition>
  <arm_group>
    <arm_group_label>ISB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interscalene brachial plexus block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aSSB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anterior Suprascapular Block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pSSB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Posterior Suprascapular Block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ISB</intervention_name>
    <description>ISB block with 0.5% ropivicaine 15mls ( 45mg )</description>
    <arm_group_label>ISB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>aSSB</intervention_name>
    <description>aSSB block with 0.5% ropivicaine 15mls ( 45mg )</description>
    <arm_group_label>aSSB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pSSB</intervention_name>
    <description>pSSB block with 0.5% ropivicaine 15mls ( 45mg )</description>
    <arm_group_label>pSSB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective arthroscopic shoulder surgery under general&#xD;
             anaesthesia&#xD;
&#xD;
          -  Patients 21 years old and above&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status 1 to 3&#xD;
&#xD;
          -  BMI 18-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give consent or inability to communicate/ cooperate&#xD;
&#xD;
          -  Patients with chronic use of strong opioids (morphine, oxycodone)&#xD;
&#xD;
          -  Patients with allergy to local anaesthetics or any drugs included in the study&#xD;
&#xD;
          -  Patients with contraindications for regional anaesthesia such as coagulopathy&#xD;
&#xD;
          -  Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy&#xD;
&#xD;
          -  Patients with pre-existing lung disease (COPD, uncontrolled asthma)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yean Chin Lim</last_name>
    <role>Principal Investigator</role>
    <affiliation>CGH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 5, 2019</last_update_submitted>
  <last_update_submitted_qc>May 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277326
org study id: 2017/2459
nct id: NCT03277326
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung
      function and analgesia
Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries.
      However, it is associated with several side effects, in particular, a high incidence of
      phrenic nerve blockade.

      The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has
      a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches
      for the suprascapular nerve block, anterior and posterior. The anterior approach may still
      result in some degree of impairment of lung function.

      The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB.
      Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pulmonary function
time frame: 2 years
description: To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block
measure: Analgesic effects and complications
time frame: 2 years
description: Analgesic effect (pain scores, opioid consumption, opioid related side effects), degree of motor blockade and incidence of adverse effects of blocks (Horner's syndrome, hoarseness of voice)
arm group label: ISB
arm group type: Active Comparator
description: Interscalene brachial plexus block
arm group label: aSSB
arm group type: Active Comparator
description: Anterior Suprascapular Block
arm group label: pSSB
arm group type: Active Comparator
description: Posterior Suprascapular Block
intervention type: Procedure
intervention name: ISB
description: ISB block with 0.5% ropivicaine 15mls ( 45mg )
arm group label: ISB
intervention type: Procedure
intervention name: aSSB
description: aSSB block with 0.5% ropivicaine 15mls ( 45mg )
arm group label: aSSB
intervention type: Procedure
intervention name: pSSB
description: pSSB block with 0.5% ropivicaine 15mls ( 45mg )
arm group label: pSSB
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Yean Chin Lim
role: Principal Investigator
affiliation: CGH
facility: 
country: Singapore
responsible party type: Sponsor
sharing ipd: No