xml: <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/NCT05978427</url>
    </required_header>
    <id_info>
      <org_study_id>superior trunk vs interscalene</org_study_id>
      <nct_id>NCT05978427</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries</brief_title>
    <official_title>Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        Efficacy and safety of superior trunk block versus interscalene block for post-operative&#xD;
        analgesia in shoulder surgeries&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The interscalene brachial plexus block is the gold standard analgesic technique for surgery&#xD;
        involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic&#xD;
        paralysis, the superior trunk block was developed in an attempt to reduce major&#xD;
        complications.The utility of the superior trunk block has yet to be studied in shoulder&#xD;
        surgeries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>diaphragmatic paralysis postoperative</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>analgesic efficacy</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rescue analgesia</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>The total amount of rescue analgesia used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative nausea and vomiting</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>incidence of post operative complications as nausea an vomiting</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries</condition>
    <arm_group>
      <arm_group_label>interscalene block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants undergoing shoulder surgeries will receive ultrasound guided interscalene block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>superior trunk block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>interscalene block</intervention_name>
      <description>will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.</description>
      <arm_group_label>interscalene block group</arm_group_label>
      <arm_group_label>superior trunk block group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>superior trunk block</intervention_name>
      <description>will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.</description>
      <arm_group_label>interscalene block group</arm_group_label>
      <arm_group_label>superior trunk block group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients American Society of Anaesthesiologists physical status (ASA) is I to II.&#xD;
  &#xD;
            -  Both genders.&#xD;
  &#xD;
            -  Aged group from 21 to 50 years old.&#xD;
  &#xD;
            -  Patients electively scheduled for shoulder surgery under general anesthesia with&#xD;
               normal coagulation profile.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of the procedure or participation in the study.&#xD;
  &#xD;
            -  Any history or evidence of coagulopathy.&#xD;
  &#xD;
            -  Evidence of infection at injection site.&#xD;
  &#xD;
            -  Allergy to study drugs.&#xD;
  &#xD;
            -  Patients with pulmonary severe respiratory disease.&#xD;
  &#xD;
            -  Herniated cervical disc or cervical myelopathy.&#xD;
  &#xD;
            -  Pre-existing neuropathy of the operative limb&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mostafa N Elhanafy, msc</last_name>
      <phone>01110296565</phone>
      <phone_ext>002</phone_ext>
      <email>mostafaelhanafy@med.asu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ainshams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ainshams university</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>superior trunk block</keyword>
    <keyword>interscalene block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978427
  org study id: superior trunk vs interscalene
  nct id: NCT05978427
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Efficacy and safety of superior trunk block versus interscalene block for post-operative
        analgesia in shoulder surgeries
  The interscalene brachial plexus block is the gold standard analgesic technique for surgery
        involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic
        paralysis, the superior trunk block was developed in an attempt to reduce major
        complications.The utility of the superior trunk block has yet to be studied in shoulder
        surgeries.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: diaphragmatic paralysis postoperative
  time frame: within 24 hours after surgery
  description: o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound
  measure: analgesic efficacy
  time frame: within 24 hours after surgery
  description: o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score
  measure: rescue analgesia
  time frame: within 24 hours after surgery
  description: The total amount of rescue analgesia used
  measure: Post operative nausea and vomiting
  time frame: within 24 hours after surgery
  description: incidence of post operative complications as nausea an vomiting
  arm group label: interscalene block group
  arm group type: Active Comparator
  description: participants undergoing shoulder surgeries will receive ultrasound guided interscalene block
  arm group label: superior trunk block group
  arm group type: Active Comparator
  description: participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block
  intervention type: Procedure
  intervention name: interscalene block
  description: will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.
  arm group label: interscalene block group
  arm group label: superior trunk block group
  intervention type: Procedure
  intervention name: superior trunk block
  description: will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.
  arm group label: interscalene block group
  arm group label: superior trunk block group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mostafa N Elhanafy, msc
  phone: 01110296565
  phone ext: 002
  email: mostafaelhanafy@med.asu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Agnosia
  sharing ipd: Undecided