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/NCT06034873</url>
    </required_header>
    <id_info>
      <org_study_id>RC 17-7-2023</org_study_id>
      <nct_id>NCT06034873</nct_id>
    </id_info>
    <brief_title>Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation</brief_title>
    <official_title>Comparative Study Between Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation, Double Blinded Controlled Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Benha University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Benha University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        When someone experiences a shoulder dislocation, it can be extremely painful. Emergency&#xD;
        physicians often choose to use conscious sedation to help reduce the pain. However, some&#xD;
        patients may not be able to tolerate conscious sedation due to concerns about their ability&#xD;
        to breathe properly or the risk of inhaling fluids. A recently developed technique called&#xD;
        Ultrasound-guided Pericapsular Nerve Group (PENG) block is used to block the articular&#xD;
        branches of the shoulder and the pericapsular spread around the glenohumeral joint. The PENG&#xD;
        block is commonly used in hip surgery and is effective in providing motor-sparing analgesic&#xD;
        results.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        When someone experiences a shoulder dislocation, it can be extremely painful. Emergency&#xD;
        physicians often choose to use conscious sedation to help reduce the pain. However, some&#xD;
        patients may not be able to tolerate conscious sedation due to concerns about their ability&#xD;
        to breathe properly or the risk of inhaling fluids. In an ideal scenario, the surgeon could&#xD;
        achieve complete pain control and muscle relaxation without compromising the patient's&#xD;
        airway. There are various techniques available to facilitate shoulder reduction, including&#xD;
        interscalene block, general anesthesia, and intravenous analgesia. All of these methods can&#xD;
        help the surgeon ease the patient's pain and reduce the likelihood of complications.1 When&#xD;
        choosing the anesthesia method for reducing ASD, the top priority is ensuring the patient's&#xD;
        comfort through pain management. The anesthesia helps to relax the muscle spasms, making it&#xD;
        easier to reduce the ASD. The goal is to relocate the shoulder with minimal risk of&#xD;
        complications.&#xD;
  &#xD;
        A recently developed technique called Ultrasound-guided Pericapsular Nerve Group (PENG) block&#xD;
        is used to block the articular branches of the shoulder and the pericapsular spread around&#xD;
        the glenohumeral joint. The PENG block is commonly used in hip surgery and is effective in&#xD;
        providing motor-sparing analgesic results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>length of hospital stay</measure>
      <time_frame>1st 24 hours</time_frame>
      <description>the period when the patient stayed in the hospital</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reduction time</measure>
      <time_frame>1st hour after intervetion</time_frame>
      <description>the period from the beginning to the reduction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the visual analogue scale(VAS)</measure>
      <time_frame>30 minutes ,2,4,8,12 hours postoperative</time_frame>
      <description>ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>This Study Aims to Compare the Efficacy of Ultrasound Guided Pericapsular Nerve Block Versus iv Sedation Analgesia in Reduction of Shoulder Dislocation</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the IVAS group, the patients intravenous propofol combined with fentanyl. The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol injection and fentanyl</intervention_name>
      <description>The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain</intervention_name>
      <description>Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (ASA )classes I and II&#xD;
  &#xD;
            -  patients of either sex, above the age of 18&#xD;
  &#xD;
            -  patients will undergo dislocated shoulder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the patient's refusal to participate&#xD;
  &#xD;
            -  coagulation disorders&#xD;
  &#xD;
            -  allergy to local anesthetic&#xD;
  &#xD;
            -  history of daily opioid intake&#xD;
  &#xD;
            -  patients with cognitive impairments&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Banha faculity of medicine</name>
        <address>
          <city>Banhā</city>
          <state>Elqalyoubea</state>
          <zip>13511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatma Ahmed Abdelfataah, MD</last_name>
        <phone>00201027011148</phone>
        <email>drfatmaahmed86@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Benha University</investigator_affiliation>
      <investigator_full_name>Fatma Ahmed Abdel Fatah</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Dislocations</mesh_term>
      <mesh_term>Shoulder Dislocation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
      <mesh_term>Propofol</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06034873
  org study id: RC 17-7-2023
  nct id: NCT06034873
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  When someone experiences a shoulder dislocation, it can be extremely painful. Emergency
        physicians often choose to use conscious sedation to help reduce the pain. However, some
        patients may not be able to tolerate conscious sedation due to concerns about their ability
        to breathe properly or the risk of inhaling fluids. A recently developed technique called
        Ultrasound-guided Pericapsular Nerve Group (PENG) block is used to block the articular
        branches of the shoulder and the pericapsular spread around the glenohumeral joint. The PENG
        block is commonly used in hip surgery and is effective in providing motor-sparing analgesic
        results.
  When someone experiences a shoulder dislocation, it can be extremely painful. Emergency
        physicians often choose to use conscious sedation to help reduce the pain. However, some
        patients may not be able to tolerate conscious sedation due to concerns about their ability
        to breathe properly or the risk of inhaling fluids. In an ideal scenario, the surgeon could
        achieve complete pain control and muscle relaxation without compromising the patient's
        airway. There are various techniques available to facilitate shoulder reduction, including
        interscalene block, general anesthesia, and intravenous analgesia. All of these methods can
        help the surgeon ease the patient's pain and reduce the likelihood of complications.1 When
        choosing the anesthesia method for reducing ASD, the top priority is ensuring the patient's
        comfort through pain management. The anesthesia helps to relax the muscle spasms, making it
        easier to reduce the ASD. The goal is to relocate the shoulder with minimal risk of
        complications.
  
        A recently developed technique called Ultrasound-guided Pericapsular Nerve Group (PENG) block
        is used to block the articular branches of the shoulder and the pericapsular spread around
        the glenohumeral joint. The PENG block is commonly used in hip surgery and is effective in
        providing motor-sparing analgesic results.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: length of hospital stay
  time frame: 1st 24 hours
  description: the period when the patient stayed in the hospital
  measure: reduction time
  time frame: 1st hour after intervetion
  description: the period from the beginning to the reduction
  measure: the visual analogue scale(VAS)
  time frame: 30 minutes ,2,4,8,12 hours postoperative
  description: ranges from 0 to 10, with 0 representing no pain and 10 being the most intense pain possible.
  arm group label: Group A
  arm group type: Active Comparator
  description: In the IVAS group, the patients intravenous propofol combined with fentanyl. The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.
  arm group label: Group B
  arm group type: Active Comparator
  description: Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
  intervention type: Drug
  intervention name: Propofol injection and fentanyl
  description: The sequence will be to inject fentanyl 1 μg•kg-1•min-1 first within 1 min and then inject propofol 2 mg•kg-1•min-1.
  arm group label: Group A
  intervention type: Drug
  intervention name: Bupivacain
  description: Patients will be anesthetized with ultrasound-guided pericapsular nerve group block (PENG block) using 20 ml of 0.25% bupivacaine.
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Benha University
  investigator full name: Fatma Ahmed Abdel Fatah
  investigator title: lecturer
  mesh term: Joint Dislocations
  mesh term: Shoulder Dislocation
  mesh term: Fentanyl
  mesh term: Bupivacaine
  mesh term: Propofol