<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/NCT03294291</url>
  </required_header>
  <id_info>
    <org_study_id>2017/10-08</org_study_id>
    <nct_id>NCT03294291</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient</brief_title>
  <official_title>Quadratus Lumborum Block Versus Caudal Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam 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 purpose of this research study is to find the best way to decrease pain in children whom&#xD;
      have had low abdominal surgery. Investigators will perform two technique;Caudal block or&#xD;
      Quadratus lumborum block .The method used is often chosen by which one the doctor has more&#xD;
      experience using. The Investigator plans to find out if one of the methods is more effective&#xD;
      and/or safer than the other method.&#xD;
&#xD;
      The results of this study will help learn how to best control pain in children having surgery&#xD;
      low abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children aged 1-9 years undergoing lower abdominal surgeries would be recruited in this&#xD;
      randomized study.&#xD;
&#xD;
      Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood&#xD;
      pressure.&#xD;
&#xD;
      After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane&#xD;
      inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered&#xD;
      intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed,&#xD;
      lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval,&#xD;
      informed written consent will be obtained from all patients.&#xD;
&#xD;
      Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal&#xD;
      hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus&#xD;
      lumborum block or caudal block at the begin of surgery.&#xD;
&#xD;
      All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will&#xD;
      receive paracetamol if requirement for postoperative analgesia.All patient will transfer from&#xD;
      PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.&#xD;
&#xD;
      All patients will be assessed postoperatively by a blinded investigator: in the&#xD;
      postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC and&#xD;
      Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</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>All Children will be randomly assigned to one of 2 groups of 25 patients each using a computer-generated number table.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Use of analgesic consumption</measure>
    <time_frame>24 hour</time_frame>
    <description>paracetamol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flacc score( face, legs, activity, cry, consolability)</measure>
    <time_frame>1,2,4,6,12,24 hou</time_frame>
    <description>By investigators until hospital discharge, then through telephone interview with parents after that</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent satisfaction scores</measure>
    <time_frame>24 hour</time_frame>
    <description>By investigators until hospital discharge, then through telephone interview with parents after that</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first use of analgesic</measure>
    <time_frame>24 hour</time_frame>
    <description>By investigators until hospital discharge, then through telephone interview with parents after that</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Quadratus Lumborum block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caudal block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus lumborum block</intervention_name>
    <description>Postoperative pain procedure</description>
    <arm_group_label>Quadratus Lumborum block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Caudal block</intervention_name>
    <description>Postoperative pain procedure</description>
    <arm_group_label>Caudal block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 1-9&#xD;
&#xD;
          2. ASA physical status I-II&#xD;
&#xD;
          3. Undergoing unilateral low abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of developmental delay or mental retardation, which will make observational&#xD;
             pain intensity assessment difficult&#xD;
&#xD;
          2. Parent refusal&#xD;
&#xD;
          3. History of allergic reactions to local anesthetics&#xD;
&#xD;
          4. Rash or infection at the injection site&#xD;
&#xD;
          5. Anatomical abnormality&#xD;
&#xD;
          6. Bleeding diatheses&#xD;
&#xD;
          7. Coagulopathy,&#xD;
&#xD;
          8. History of diseases&#xD;
&#xD;
               1. renal&#xD;
&#xD;
               2. hepatic&#xD;
&#xD;
               3. cardiac&#xD;
&#xD;
               4. upper or lower airway&#xD;
&#xD;
               5. neurological&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gözen Öksüz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kahramanmaras Sutcu Imam University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KahramanmarasSIU</name>
      <address>
        <city>Kahramanmaraş</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.</citation>
    <PMID>28759502</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Gözen Öksüz</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>


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/NCT03294291
org study id: 2017/10-08
nct id: NCT03294291
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to find the best way to decrease pain in children whom
      have had low abdominal surgery. Investigators will perform two technique;Caudal block or
      Quadratus lumborum block .The method used is often chosen by which one the doctor has more
      experience using. The Investigator plans to find out if one of the methods is more effective
      and/or safer than the other method.

      The results of this study will help learn how to best control pain in children having surgery
      low abdominal surgery.
Children aged 1-9 years undergoing lower abdominal surgeries would be recruited in this
      randomized study.

      Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood
      pressure.

      After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane
      inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered
      intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed,
      lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval,
      informed written consent will be obtained from all patients.

      Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal
      hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus
      lumborum block or caudal block at the begin of surgery.

      All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will
      receive paracetamol if requirement for postoperative analgesia.All patient will transfer from
      PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

      All patients will be assessed postoperatively by a blinded investigator: in the
      postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC and
      Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All Children will be randomly assigned to one of 2 groups of 25 patients each using a computer-generated number table.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Use of analgesic consumption
time frame: 24 hour
description: paracetamol
measure: Flacc score( face, legs, activity, cry, consolability)
time frame: 1,2,4,6,12,24 hou
description: By investigators until hospital discharge, then through telephone interview with parents after that
measure: Parent satisfaction scores
time frame: 24 hour
description: By investigators until hospital discharge, then through telephone interview with parents after that
measure: Time to first use of analgesic
time frame: 24 hour
description: By investigators until hospital discharge, then through telephone interview with parents after that
arm group label: Quadratus Lumborum block group
arm group type: Active Comparator
description: After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.
arm group label: Caudal block
arm group type: Active Comparator
description: After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.
intervention type: Procedure
intervention name: Quadratus lumborum block
description: Postoperative pain procedure
arm group label: Quadratus Lumborum block group
intervention type: Procedure
intervention name: Caudal block
description: Postoperative pain procedure
arm group label: Caudal block
criteria: 
gender: All
minimum age: 1 Year
maximum age: 9 Years
healthy volunteers: No
last name: Gözen Öksüz, M.D.
role: Principal Investigator
affiliation: Kahramanmaras Sutcu Imam University
facility: 
country: Turkey
citation: Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PMID: 28759502
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Gözen Öksüz
investigator title: Assistant Professor
mesh term: Pain, Postoperative
sharing ipd: No