<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/NCT03780790</url>
  </required_header>
  <id_info>
    <org_study_id>2018/1076</org_study_id>
    <nct_id>NCT03780790</nct_id>
  </id_info>
  <brief_title>Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics</brief_title>
  <official_title>A Prospective Randomized Trial Comparing Analgesic Effects of Three Ultrasound-guided Regionel Anesthetic Techniques in Pediatrics: Caudal Analgesia, Transversus Abdominis Plane and Quadratus Lumborum Blocks</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>
      This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic&#xD;
      techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum&#xD;
      block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry,&#xD;
      Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and&#xD;
      total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to&#xD;
      observe the side effects of these techniques such as nausea, vomiting, bradycardia,&#xD;
      hypotension, respiratory depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides&#xD;
      effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is&#xD;
      considered the gold standart regional technique for pain management after lower abdominal&#xD;
      surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform&#xD;
      caudal block, demostrating cannule placement and precise deposition of local anesthetic in&#xD;
      the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1&#xD;
      dermatomes and provides postoperative pain relief after lower abdominal surgery with lower&#xD;
      complication rate rather than caudal block but it may not prevent traction on the peritoneal&#xD;
      sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area&#xD;
      affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative&#xD;
      analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain&#xD;
      scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are&#xD;
      total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention,&#xD;
      bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain&#xD;
      due to incision after 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Actual">February 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>
    <intervention_model_description>RANDOMISED DOUBLE BLINDED INTERVENTIONAL</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Face, Legs Activity, Cry, Consolability (FLACC) scores</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
    <description>Hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who require rescue analgesic</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Number of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First analgesic requirement time</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Duration of postoperative analgesia</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of side effects</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Nausea, vomiting</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>up to first week</time_frame>
    <description>Hematoma, dural puncture, infections</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to first mobilization</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Time to first mobilization</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-guided quadratus lumborum block will be performed with 0,5 ml/kg 0.25% Bupivacaine in the anterior layer of the thoracolumbar fascia between psoas major and quadratus lumborum muscles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US- guided transversus abdominis plane block will be performed with 0,5 ml/kg 0.25% Bupivacaine into the fascial plane between internal oblique muscle and transversus abdominis muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caudal Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>% 0,25</description>
    <arm_group_label>Caudal Block</arm_group_label>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing lower abdominal surgery&#xD;
&#xD;
          -  ASA(American Society of Anestesiology)1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  denial of patient or parents,&#xD;
&#xD;
          -  infection on the local anesthetic application area&#xD;
&#xD;
          -  infection in central nervous system&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  brain tumours&#xD;
&#xD;
          -  known allergy against local anesthetics&#xD;
&#xD;
          -  anatomical difficulties&#xD;
&#xD;
          -  with preexisting cardiac dysfunction&#xD;
&#xD;
          -  with history of renal and/or hepatic dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meltem Savran Karadeniz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University Faculty of Medicine Department of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University</name>
      <address>
        <city>Istanbul</city>
        <zip>34</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/26846889</url>
    <description>Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27555187</url>
    <description>Comparison of caudal epidural block and ultrasonography-guided transversus abdominis plane block for pain relief in children undergoing lower abdominal surgery.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28759502</url>
    <description>Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial.</description>
  </link>
  <link>
    <url>https://www.nysora.com/ultrasound-guided-transversus-abdominis-plane-quadratus-lumborum-blocks</url>
    <description>Ultrasound-Guided Transversus Abdominis Plane and Quadratus Lumborum Blocks</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Meltem Savran Karadeniz</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <keyword>quadratus lumborum block</keyword>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>caudal block</keyword>
  <keyword>ultrasound-guided</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03780790
org study id: 2018/1076
nct id: NCT03780790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic
      techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum
      block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry,
      Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and
      total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to
      observe the side effects of these techniques such as nausea, vomiting, bradycardia,
      hypotension, respiratory depression.
Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides
      effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is
      considered the gold standart regional technique for pain management after lower abdominal
      surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform
      caudal block, demostrating cannule placement and precise deposition of local anesthetic in
      the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1
      dermatomes and provides postoperative pain relief after lower abdominal surgery with lower
      complication rate rather than caudal block but it may not prevent traction on the peritoneal
      sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area
      affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative
      analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain
      scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are
      total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention,
      bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain
      due to incision after 2 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
primary purpose: Screening
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Face, Legs Activity, Cry, Consolability (FLACC) scores
time frame: up to 48 hours
description: It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.
measure: Hospital stay
time frame: Through study completion, an average of 1 week
description: Hospitalisation
measure: Number of patients who require rescue analgesic
time frame: up to 48 hours
description: Number of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours
measure: First analgesic requirement time
time frame: Up to 48 hours
description: Duration of postoperative analgesia
measure: Incidence of side effects
time frame: up to 48 hours
description: Nausea, vomiting
measure: Incidence of complications
time frame: up to first week
description: Hematoma, dural puncture, infections
measure: Time to first mobilization
time frame: up to 48 hours
description: Time to first mobilization
arm group label: Quadratus Lumborum Block
arm group type: Active Comparator
description: US-guided quadratus lumborum block will be performed with 0,5 ml/kg 0.25% Bupivacaine in the anterior layer of the thoracolumbar fascia between psoas major and quadratus lumborum muscles
arm group label: Transversus Abdominis Plane Block
arm group type: Active Comparator
description: US- guided transversus abdominis plane block will be performed with 0,5 ml/kg 0.25% Bupivacaine into the fascial plane between internal oblique muscle and transversus abdominis muscle
arm group label: Caudal Block
arm group type: Active Comparator
description: US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL
intervention type: Drug
intervention name: Bupivacaine
description: % 0,25
arm group label: Caudal Block
arm group label: Quadratus Lumborum Block
arm group label: Transversus Abdominis Plane Block
other name: Marcaine
criteria: 
gender: All
minimum age: 12 Months
maximum age: 12 Years
healthy volunteers: No
last name: Meltem Savran Karadeniz
role: Principal Investigator
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/26846889
description: Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials.
url: https://www.ncbi.nlm.nih.gov/pubmed/27555187
description: Comparison of caudal epidural block and ultrasonography-guided transversus abdominis plane block for pain relief in children undergoing lower abdominal surgery.
url: https://www.ncbi.nlm.nih.gov/pubmed/28759502
description: Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial.
url: https://www.nysora.com/ultrasound-guided-transversus-abdominis-plane-quadratus-lumborum-blocks
description: Ultrasound-Guided Transversus Abdominis Plane and Quadratus Lumborum Blocks
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Meltem Savran Karadeniz
investigator title: Associated Professor
mesh term: Bupivacaine