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/NCT06020781</url>
    </required_header>
    <id_info>
      <org_study_id>KFSIRB200-51</org_study_id>
      <nct_id>NCT06020781</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block</brief_title>
    <official_title>Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kafrelsheikh University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kafrelsheikh 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>
        Our trial aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg&#xD;
        dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives&#xD;
        in ultrasound-guided supraclavicular brachial plexus block for anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to&#xD;
        local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe&#xD;
        when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different&#xD;
        doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided&#xD;
        supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of&#xD;
        dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower&#xD;
        heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence,&#xD;
        a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Success rate.</measure>
      <time_frame>30 min after block performance</time_frame>
      <description>Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total pethidine consumption.</measure>
      <time_frame>24 hours postoperative.</time_frame>
      <description>Visual analog scale ≥ 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain score.</measure>
      <time_frame>24 hours postoperative.</time_frame>
      <description>Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative..</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean arterial blood pressure</measure>
      <time_frame>From preoperatively till the end of surgery</time_frame>
      <description>Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>From preoperatively till the end of surgery</time_frame>
      <description>Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative side effects.</measure>
      <time_frame>24 hours postoperative</time_frame>
      <description>Complication related to the block or adverse events of the administered drugs.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Dexmedetomidine</condition>
    <condition>Bupivacaine</condition>
    <condition>Supraclavicular Brachial Plexus Block</condition>
    <arm_group>
      <arm_group_label>Bupivacaine and Dexmedetomidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>20 ml Bupivacaine without additives</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>30 ml bupivacaine without additives</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>bupivacaine and dexmedetomidine.</intervention_name>
      <description>patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.</description>
      <arm_group_label>Bupivacaine and Dexmedetomidine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>bupivacaine only</intervention_name>
      <description>patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives</description>
      <arm_group_label>20 ml Bupivacaine without additives</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>bupivacaine</intervention_name>
      <description>patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.</description>
      <arm_group_label>30 ml bupivacaine without additives</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologist (ASA) grade I or II patients&#xD;
  &#xD;
            -  both sexes&#xD;
  &#xD;
            -  scheduled for elective upper limb surgery below mid-humerus level under Ultrasound&#xD;
               -guided Supraclavicular brachial plexus block .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  with pre-existing peripheral neuropathy of upper limb.&#xD;
  &#xD;
            -  Bleeding disorders.&#xD;
  &#xD;
            -  Infection at injection site.&#xD;
  &#xD;
            -  Untreated pneumothorax.&#xD;
  &#xD;
            -  Patients on adrenoreceptor agonist or antagonist therapy.&#xD;
  &#xD;
            -  History of severe cardiac,.respiratory, hepatic, or renal disease.&#xD;
  &#xD;
            -  pregnancy and known hypersensitivity to the study drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gamal H Shams, MD</last_name>
      <phone>00201095927971</phone>
      <email>gamal.shams2@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kafrelsheikh University</name>
        <address>
          <city>Kafr Ash Shaykh</city>
          <state>Kafrelsheikh</state>
          <zip>33516</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Gamal H Shams, MD</last_name>
        <phone>00201095927971</phone>
        <email>gamal.shams2@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
      <investigator_full_name>Gamal Hendawy Shams</investigator_full_name>
      <investigator_title>Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author.</ipd_access_criteria>
    </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/NCT06020781
  org study id: KFSIRB200-51
  nct id: NCT06020781
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our trial aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg
        dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives
        in ultrasound-guided supraclavicular brachial plexus block for anesthesia.
  Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to
        local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe
        when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different
        doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided
        supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of
        dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower
        heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence,
        a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Success rate.
  time frame: 30 min after block performance
  description: Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.
  measure: Total pethidine consumption.
  time frame: 24 hours postoperative.
  description: Visual analog scale ≥ 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.
  measure: Pain score.
  time frame: 24 hours postoperative.
  description: Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative..
  measure: Mean arterial blood pressure
  time frame: From preoperatively till the end of surgery
  description: Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.
  measure: Heart rate
  time frame: From preoperatively till the end of surgery
  description: Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.
  measure: Postoperative side effects.
  time frame: 24 hours postoperative
  description: Complication related to the block or adverse events of the administered drugs.
  arm group label: Bupivacaine and Dexmedetomidine
  arm group type: Experimental
  description: Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
  arm group label: 20 ml Bupivacaine without additives
  arm group type: Active Comparator
  description: Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.
  arm group label: 30 ml bupivacaine without additives
  arm group type: Active Comparator
  description: Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
  intervention type: Drug
  intervention name: bupivacaine and dexmedetomidine.
  description: patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
  arm group label: Bupivacaine and Dexmedetomidine
  intervention type: Drug
  intervention name: bupivacaine only
  description: patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives
  arm group label: 20 ml Bupivacaine without additives
  intervention type: Drug
  intervention name: bupivacaine
  description: patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
  arm group label: 30 ml bupivacaine without additives
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Gamal H Shams, MD
  phone: 00201095927971
  email: gamal.shams2@gmail.com
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Kafrelsheikh University
  investigator full name: Gamal Hendawy Shams
  investigator title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University
  mesh term: Dexmedetomidine
  mesh term: Bupivacaine
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author.