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/NCT05979376</url>
    </required_header>
    <id_info>
      <org_study_id>E-83045809-604.01.01-631721</org_study_id>
      <nct_id>NCT05979376</nct_id>
    </id_info>
    <brief_title>Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block</brief_title>
    <official_title>Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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>
        This prospective double blinded study will be conducted over 60 pediatric patients ASA&#xD;
        (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who&#xD;
        will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3&#xD;
        study groups: Control group that only received local anesthetics ( bupivacaine) Group II&#xD;
        bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the&#xD;
        dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.&#xD;
  &#xD;
        Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded.&#xD;
        When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion&#xD;
        bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose&#xD;
        of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first&#xD;
        2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were&#xD;
        evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting,&#xD;
        and other side effects were recorded if present.&#xD;
  &#xD;
        Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded&#xD;
        within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative&#xD;
        complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will&#xD;
        be recorded.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Actual">April 1, 2023</completion_date>
    <primary_completion_date type="Actual">April 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the time to first rescue analgesic requirement</measure>
      <time_frame>24 hours</time_frame>
      <description>the time to first rescue analgesic requirement within the first 24 postoperative hours,</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative pain scores FLACC (face, legs, activity, cry, and consolability)</measure>
      <time_frame>24 hours</time_frame>
      <description>postoperative pain assessment score in children (The scale is scored in a range of 0-10 with 0 representing no pain, 10 representing maximum pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>additional analgesic consumption</measure>
      <time_frame>24 hours</time_frame>
      <description>total analgesic consuption within 24 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative sedation scores RAMSEY (Ramsey sedation scale)</measure>
      <time_frame>1 hour</time_frame>
      <description>patient's sedation scores within postoperative first one hour (Ramsey sedation score is scored in a range of 1-6 with 1 representing awake; agitated or restless, 6 representing Asleep; no response to glabellar tap or loud auditory stimulus)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of complications</measure>
      <time_frame>24 hours</time_frame>
      <description>Incidence of intraoperative and postoperative complications or side effects</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">60</enrollment>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>Group I (Control group)</arm_group_label>
      <description>group I: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <description>groupII: quadratus lumborum block with 0,25%bupivacaine 0,5 ml/kg and dexmedetomidine 0,5 mcg/kg as an adjuvant</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group III</arm_group_label>
      <description>groupIII: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg and dexmedetomidine 1 mcg/kg as an adjuvant</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          pediatric patient children aged 1-7 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The study included children aged 1-7 years with ASA (American Society of Anesthesiologists)&#xD;
          I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy,&#xD;
          hydrocele) with the consent of their families&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who were aged outside the range of 1-7 years, with ASA III or higher,&#xD;
               allergic to local anesthetics, had an infection in the injection area, had&#xD;
               contraindications for regional anesthesia such as coagulopathy, whose families did not&#xD;
               give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery,&#xD;
               had a body mass index of &gt;30 kg/m2, and were expected to be admitted to the intensive&#xD;
               care unit during the postoperative period were excluded from the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>PINAR Kendigelen, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>PINAR Kendigelen</name>
        <address>
          <city>Istanbul</city>
          <state>Please Select</state>
          <zip>34098</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Yagmur Gul</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>dexmedetomidine</keyword>
    <keyword>bupivacaine</keyword>
    <keyword>quadratus lumborum block</keyword>
    <keyword>postoperative pain</keyword>
    <keyword>regional anesthesia</keyword>
    <keyword>pediatric anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05979376
  org study id: E-83045809-604.01.01-631721
  nct id: NCT05979376
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This prospective double blinded study will be conducted over 60 pediatric patients ASA
        (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who
        will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3
        study groups: Control group that only received local anesthetics ( bupivacaine) Group II
        bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the
        dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.
  
        Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded.
        When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion
        bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose
        of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first
        2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were
        evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting,
        and other side effects were recorded if present.
  
        Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded
        within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative
        complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will
        be recorded.
  observational model: Case-Control
  time perspective: Prospective
  measure: the time to first rescue analgesic requirement
  time frame: 24 hours
  description: the time to first rescue analgesic requirement within the first 24 postoperative hours,
  measure: postoperative pain scores FLACC (face, legs, activity, cry, and consolability)
  time frame: 24 hours
  description: postoperative pain assessment score in children (The scale is scored in a range of 0-10 with 0 representing no pain, 10 representing maximum pain)
  measure: additional analgesic consumption
  time frame: 24 hours
  description: total analgesic consuption within 24 hours
  measure: postoperative sedation scores RAMSEY (Ramsey sedation scale)
  time frame: 1 hour
  description: patient's sedation scores within postoperative first one hour (Ramsey sedation score is scored in a range of 1-6 with 1 representing awake; agitated or restless, 6 representing Asleep; no response to glabellar tap or loud auditory stimulus)
  measure: incidence of complications
  time frame: 24 hours
  description: Incidence of intraoperative and postoperative complications or side effects
  arm group label: Group I (Control group)
  description: group I: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg
  arm group label: Group II
  description: groupII: quadratus lumborum block with 0,25%bupivacaine 0,5 ml/kg and dexmedetomidine 0,5 mcg/kg as an adjuvant
  arm group label: Group III
  description: groupIII: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg and dexmedetomidine 1 mcg/kg as an adjuvant
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 7 Years
  healthy volunteers: No
  last name: PINAR Kendigelen, Prof.
  role: Study Director
  affiliation: Istanbul University - Cerrahpasa (IUC)
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Yagmur Gul
  investigator title: Principal Investigator
  mesh term: Pain, Postoperative
  sharing ipd: No