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/NCT05969613</url>
    </required_header>
    <id_info>
      <org_study_id>Fnaumeri</org_study_id>
      <nct_id>NCT05969613</nct_id>
    </id_info>
    <brief_title>Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children</brief_title>
    <acronym>RCT</acronym>
    <official_title>Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Edward Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King Edward Medical University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Comparison of regional block, wound infiltration and caudal block for post operative pain&#xD;
        management in participants undergoing inguinal herniotomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigators are comparing three modalities (regional block, wound infiltration and caudal&#xD;
        block), for post operative pain management in participants after inguinal herniotomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2019</start_date>
    <completion_date type="Actual">June 1, 2020</completion_date>
    <primary_completion_date type="Actual">October 1, 2019</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>post operative pain -FLACC Pain sacle</measure>
      <time_frame>Within 24 hours</time_frame>
      <description>Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>post operative pain -Wong-Baker Faces pain scale</measure>
      <time_frame>Within 24 hours</time_frame>
      <description>The scale shows a series of faces ranging from a happy face at 0, or &quot;no hurt&quot;, to a crying face at 10, which represents &quot;hurts like the worst pain imaginable&quot;.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">2</enrollment>
    <condition>Inguinal Hernia</condition>
    <arm_group>
      <arm_group_label>Regional Block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bupivacaine 0.25%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wound infilteration</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bupivacaine 0.25%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>caudal block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bupivacaine 0.25%</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Regional block</intervention_name>
      <description>regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline</description>
      <arm_group_label>Regional Block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Wound infiltration</intervention_name>
      <description>Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose</description>
      <arm_group_label>Wound infilteration</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Caudal block</intervention_name>
      <description>Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose</description>
      <arm_group_label>caudal block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. •Patients under 13 years of age&#xD;
  &#xD;
            2. •Inguinal hernia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. •History of allergy to any drugs used in study documented on history.&#xD;
  &#xD;
            2. •Infection at the site of regional, caudal or local infiltration, documented on&#xD;
               clinical examination.&#xD;
  &#xD;
            3. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Months</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mamoonullah Asmati</last_name>
      <role>Principal Investigator</role>
      <affiliation>King Edward Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Hospital</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>55000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 22, 2021</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Edward Medical University</investigator_affiliation>
      <investigator_full_name>Fatima Numeri</investigator_full_name>
      <investigator_title>Dr Fatima Naumeri Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia, Inguinal</mesh_term>
    </condition_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/NCT05969613
  org study id: Fnaumeri
  nct id: NCT05969613
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Comparison of regional block, wound infiltration and caudal block for post operative pain
        management in participants undergoing inguinal herniotomy.
  Investigators are comparing three modalities (regional block, wound infiltration and caudal
        block), for post operative pain management in participants after inguinal herniotomy.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: post operative pain -FLACC Pain sacle
  time frame: Within 24 hours
  description: Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
  measure: post operative pain -Wong-Baker Faces pain scale
  time frame: Within 24 hours
  description: The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
  arm group label: Regional Block
  arm group type: Experimental
  description: Bupivacaine 0.25%
  arm group label: Wound infilteration
  arm group type: Active Comparator
  description: Bupivacaine 0.25%
  arm group label: caudal block
  arm group type: Active Comparator
  description: Bupivacaine 0.25%
  intervention type: Procedure
  intervention name: Regional block
  description: regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline
  arm group label: Regional Block
  intervention type: Procedure
  intervention name: Wound infiltration
  description: Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose
  arm group label: Wound infilteration
  intervention type: Procedure
  intervention name: Caudal block
  description: Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose
  arm group label: caudal block
  criteria: 
  gender: All
  minimum age: 2 Months
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mamoonullah Asmati
  role: Principal Investigator
  affiliation: King Edward Medical University
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: King Edward Medical University
  investigator full name: Fatima Numeri
  investigator title: Dr Fatima Naumeri Associate Professor
  mesh term: Hernia, Inguinal