<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/NCT03258736</url>
  </required_header>
  <id_info>
    <org_study_id>604.01/02-7626</org_study_id>
    <nct_id>NCT03258736</nct_id>
  </id_info>
  <brief_title>Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient</brief_title>
  <official_title>Comparison of Caudal Block and Ultrasound Guided Ilioinguinal/Iliohypogastric Block for Bilateral Inguinal Surgery in Pediatric Patient: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul 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>
      The caudal block is the most common technique for inguinal surgery. Increased use of&#xD;
      ultrasound in regional analgesia techniques has been improved the practise of the peripheral&#xD;
      nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative&#xD;
      methods to the central blocks. The aim of this study is to compare analgesic efficiency of&#xD;
      caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for&#xD;
      bilateral inguinal hernia in pediatric patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective randomized study, pediatric patients between 1- 10 years old who were&#xD;
      scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil&#xD;
      randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or&#xD;
      caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine&#xD;
      as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe&#xD;
      with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred&#xD;
      intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen.&#xD;
      Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic&#xD;
      requirement, complications and parental satisfaction. Parents will be also called for&#xD;
      analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation&#xD;
      will be performed by a researcher whom does not know which participants belong to the caudal&#xD;
      or ilioinguinal/iliohypogastric nerve block group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic requirements</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>FLACC score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Bromage scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Caudal block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Caudal block Marcaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ilionguinal/iliohypogastric block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ilionguinal/iliohypogastric block Marcaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inguinal hernia surgery</intervention_name>
    <description>repair of inguinal hernia</description>
    <arm_group_label>Caudal block</arm_group_label>
    <arm_group_label>ilionguinal/iliohypogastric block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:1- 10 year- old who were scheduled to bilateral inguinal hernia surgery&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Patients with neurological disoder, reoperation for inguinal hernia&#xD;
        surgery, coagulation disorder&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <state>Cerrahpasa</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Ayse Cigdem Tutuncu</investigator_full_name>
    <investigator_title>assoc prof</investigator_title>
  </responsible_party>
  <keyword>pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availabe from the authors</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03258736
org study id: 604.01/02-7626
nct id: NCT03258736
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The caudal block is the most common technique for inguinal surgery. Increased use of
      ultrasound in regional analgesia techniques has been improved the practise of the peripheral
      nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative
      methods to the central blocks. The aim of this study is to compare analgesic efficiency of
      caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for
      bilateral inguinal hernia in pediatric patients
In this prospective randomized study, pediatric patients between 1- 10 years old who were
      scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil
      randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or
      caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine
      as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe
      with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred
      intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen.
      Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic
      requirement, complications and parental satisfaction. Parents will be also called for
      analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation
      will be performed by a researcher whom does not know which participants belong to the caudal
      or ilioinguinal/iliohypogastric nerve block group
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Analgesic requirements
time frame: up to 24 hours
description: FLACC score
measure: Postoperative complications
time frame: up to 24 hours
description: Bromage scale
arm group label: Caudal block
arm group type: Other
description: Caudal block Marcaine
arm group label: ilionguinal/iliohypogastric block
arm group type: Other
description: ilionguinal/iliohypogastric block Marcaine
intervention type: Procedure
intervention name: inguinal hernia surgery
description: repair of inguinal hernia
arm group label: Caudal block
arm group label: ilionguinal/iliohypogastric block
criteria: 
gender: All
minimum age: 1 Year
maximum age: 10 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ayse Cigdem Tutuncu
investigator title: assoc prof
sharing ipd: No
ipd description: Availabe from the authors