<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/NCT03811392</url>
  </required_header>
  <id_info>
    <org_study_id>050108018(18/12/2018)</org_study_id>
    <nct_id>NCT03811392</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children</brief_title>
  <official_title>Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</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>
      To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing&#xD;
      postoperative pain, opioid consumption, and recovery time following elective inguinal&#xD;
      herniorraphy.&#xD;
&#xD;
      The primary outcome:&#xD;
&#xD;
      • to compare between caudal block and ultrasound guided quadratus lamborum block.&#xD;
&#xD;
      The secondary outcome:&#xD;
&#xD;
        -  duration of postoperative analgesia.&#xD;
&#xD;
        -  incidence of postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed&#xD;
      consent from the guardians of each patient, the present study will be carried out in&#xD;
      Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society&#xD;
      of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective&#xD;
      inguinal herniorraphy in a randomized double blinded study.&#xD;
&#xD;
      The sample size was calculated by High Institute of Public Health.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or&#xD;
      bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal&#xD;
&#xD;
      The patients will be randomly divided by closed envelope technique into two groups:&#xD;
&#xD;
      Group I: 30 patients will receive a caudal block after induction of general anaesthesia.&#xD;
&#xD;
      Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior&#xD;
      transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL&#xD;
      muscles and the thoracolumbar fascia. .&#xD;
&#xD;
      METHOD&#xD;
&#xD;
      Preoperative Assessment:&#xD;
&#xD;
        1. History taking&#xD;
&#xD;
        2. Clinical examination&#xD;
&#xD;
        3. Routine laboratory investigations including complete blood picture, bleeding and&#xD;
           clotting time, prothrombin time, partial thromboplastin time, blood urea, serum&#xD;
           creatinine and fasting blood sugar will be done to every patient.&#xD;
&#xD;
      Pre anaesthetic preparation and premedication&#xD;
&#xD;
        -  Nothing per mouth for 6 hours before surgery.&#xD;
&#xD;
        -  A peripheral cannula (22 G) will be inserted in all patients.&#xD;
&#xD;
        -  Administration 0f 10ml/kg. lactated Ringer's solution.&#xD;
&#xD;
        -  All patients will be premedicated with atropine 0,1mg/kg. administered IM to all the&#xD;
           patients 30 min prior to surgery.&#xD;
&#xD;
      A multi-channel monitor will be attached to the patient to display:&#xD;
&#xD;
        1. Continuous lead II electro cardiogram (ECG) monitoring.&#xD;
&#xD;
        2. Non-invasive blood pressure measurement (NIBP) mmHg.&#xD;
&#xD;
        3. Arterial oxygen saturation by pulse oximeter (SpO2%).&#xD;
&#xD;
        4. End-tidal capnogram (ETco2).&#xD;
&#xD;
      Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in&#xD;
      oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a&#xD;
      laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained&#xD;
      with sevoflurane 2% and 50% air in oxygen.&#xD;
&#xD;
        -  All procedures (Caudal , QL) will be performed by the same anaesthetist after placement&#xD;
           of the LMA before surgery.&#xD;
&#xD;
        -  The patients of both groups were admitted to the ward and receive standard postoperative&#xD;
           analgesic regimen composed of regular paracetamol 15mg./kg. every 8hours.&#xD;
&#xD;
      According to the studied group, patients will receive after induction either Group I: caudal&#xD;
      block. Group II: Quadratus lamborum block.&#xD;
&#xD;
      Technique:&#xD;
&#xD;
      -For the caudal block, the patients were first inducted by GA and then they were placed in&#xD;
      the altered left lateral position. The block site, which was mainly at the sacral hiatus, was&#xD;
      sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a&#xD;
      23-gage short needle injection was used with the bevel towards the abdomen to puncture the&#xD;
      sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have&#xD;
      punctured, the needle was tilted more towards the skin surface and the needle was inserted&#xD;
      2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid&#xD;
      extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25%&#xD;
      bupivacaine 1 ml/kg was infused. (8,9).&#xD;
&#xD;
      In the QL block group, the probe will be placed anterior and superior to the iliac crest, and&#xD;
      the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will&#xD;
      be followed posterolaterally until the posterior border of the muscle will be identified.&#xD;
      When the probe is tilted to the attachment site of both the internal abdominal oblique muscle&#xD;
      and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar&#xD;
      fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex&#xD;
      needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle&#xD;
      will be directed from anterolateral to posteromedial after making a negative aspiration test&#xD;
      with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection.&#xD;
      An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the&#xD;
      thoracolumbar fascia(10).&#xD;
&#xD;
      The operation will be planned to begin 7 to 10 minutes after the block is applied , and all&#xD;
      patients will be operated on with a standardized technique.&#xD;
&#xD;
      Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability )&#xD;
      behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater&#xD;
      ibuprofen 7mg/kg will be administered orally .&#xD;
&#xD;
      Any complications occurring during the procedure will be recorded and treated :&#xD;
&#xD;
        -  Hypotension : In childhood, hypotension can be considered significant when there is&#xD;
           20-30% reduction from baseline in systolic blood pressure ( SBP ) (12) . Treated by&#xD;
           administering fluid bolus(13) .&#xD;
&#xD;
        -  Bradycardia : Defined as(14):&#xD;
&#xD;
      &lt; 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine .&#xD;
&#xD;
      • Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) .&#xD;
&#xD;
      MEASURMENTS:&#xD;
&#xD;
      The following parameters will be measured for all patients:&#xD;
&#xD;
        -  Pain levels will be assessed using a FLACC (Face, Legs ,Activity, Cry, Consolability)&#xD;
           behavioral pain assessment scale postoperatively after recovery at 30minutes and at 1,&#xD;
           2, 4, 6, 12, and24 hours by the nurses and a second anesthetist will be blinded to&#xD;
           groupassignment in the recovery room and the surgical ward .&#xD;
&#xD;
        -  Duration of analgesia measured by time from start of the block to the first request for&#xD;
           analgesia .&#xD;
&#xD;
        -  Total analgesic dose .&#xD;
&#xD;
        -  Postoperative complications, such as hypotension, arrhythmia, bradycardia,, nausea, or&#xD;
           vomiting .&#xD;
&#xD;
        -  Parent satisfaction. Satisfaction levels of the parents will be given verbally as a&#xD;
           level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the&#xD;
           highest level at 10(16).&#xD;
&#xD;
      A-Haemodynamics&#xD;
&#xD;
        1. Heart rate (beats/minute) and rhythm.&#xD;
&#xD;
        2. Non-invasive mean arterial blood pressure (MABP) in mm Hg. Timing&#xD;
&#xD;
             -  Baseline: before the block.&#xD;
&#xD;
             -  Just after the block.&#xD;
&#xD;
             -  Every 5 min during surgery.&#xD;
&#xD;
             -  Every 2 hour after surgery.&#xD;
&#xD;
      B-Need for intraoperative rescue analgesia:&#xD;
&#xD;
      Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the&#xD;
      absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline&#xD;
      values obtained just before surgical incision. An intraoperative increase in blood pressure&#xD;
      (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a&#xD;
      rescue opioid (fentanyl; 1mcg/kg).&#xD;
&#xD;
      C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores&#xD;
      were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving&#xD;
      into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120&#xD;
      min. post-surgery, the last pain scores were taken. The pain scores were taken when the&#xD;
      patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was&#xD;
      infused.&#xD;
&#xD;
      D-Analgesic requirements&#xD;
&#xD;
        -  Total dose of analgesics postoperative will be recorded&#xD;
&#xD;
        -  Time of first analgesic dose given. E-Incidence of postoperative complications: e.g.:&#xD;
           nausea , vomiting and respiratory depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain.</measure>
    <time_frame>24 hours</time_frame>
    <description>FLACC Scale from 0 to 10</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Hernioraphy/Caudal block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive a caudal block after induction of general anaesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hernioraphy/Quadratus Lumborum block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive ultrasound guided quadrates lumborum block (QL )</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernioraphy/Caudal block</intervention_name>
    <description>30 patients will receive a caudal block after induction of general anaesthesia</description>
    <arm_group_label>Hernioraphy/Caudal block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernioraphy/Quadratus Lumborum block</intervention_name>
    <description>30 patients will receive ultrasound guided quadrates lumborum block</description>
    <arm_group_label>Hernioraphy/Quadratus Lumborum block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients , aged 2 to 5 years and American Society of Anaesthesiologists&#xD;
        (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a&#xD;
        randomized double blinded study.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or&#xD;
        bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of &quot;normal&quot; and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8. doi: 10.1007/s002680020072.</citation>
    <PMID>11369993</PMID>
  </reference>
  <reference>
    <citation>Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.</citation>
    <PMID>8867249</PMID>
  </reference>
  <reference>
    <citation>Johr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e.</citation>
    <PMID>23614955</PMID>
  </reference>
  <reference>
    <citation>Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.</citation>
    <PMID>15781509</PMID>
  </reference>
  <reference>
    <citation>Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60.</citation>
    <PMID>15886601</PMID>
  </reference>
  <reference>
    <citation>Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.</citation>
    <PMID>22630613</PMID>
  </reference>
  <reference>
    <citation>Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.</citation>
    <PMID>24249997</PMID>
  </reference>
  <reference>
    <citation>Waldman SD. Caudal epidural nerve block: prone position. In: Atlas of Interventional Pain Management, 2nd edn. Philadelphia: Saunders, 2004 ; 380-92</citation>
  </reference>
  <reference>
    <citation>Machotta A, Risse A, Bercker S, Streich R, Pappert D. Comparison between instillation of bupivacaine versus caudal analgesia for postoperative analgesia following inguinal herniotomy in children. Paediatr Anaesth. 2003 Jun;13(5):397-402. doi: 10.1046/j.1460-9592.2003.01080.x.</citation>
    <PMID>12791112</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.</citation>
    <PMID>9220806</PMID>
  </reference>
  <reference>
    <citation>Nafiu OO, Voepel-Lewis T, Morris M, Chimbira WT, Malviya S, Reynolds PI, Tremper KK. How do pediatric anesthesiologists define intraoperative hypotension? Paediatr Anaesth. 2009 Nov;19(11):1048-53. doi: 10.1111/j.1460-9592.2009.03140.x. Epub 2009 Oct 1.</citation>
    <PMID>19796350</PMID>
  </reference>
  <reference>
    <citation>Pawar D. Common post-operative complications in children. Indian J Anaesth. 2012 Sep;56(5):496-501. doi: 10.4103/0019-5049.103970.</citation>
    <PMID>23293390</PMID>
  </reference>
  <reference>
    <citation>Chiu SN, Lin LY, Wang JK, Lu CW, Chang CW, Lin MT, Hua YC, Lue HC, Wu MH. Long-term outcomes of pediatric sinus bradycardia. J Pediatr. 2013 Sep;163(3):885-9.e1. doi: 10.1016/j.jpeds.2013.03.054. Epub 2013 Apr 25.</citation>
    <PMID>23623512</PMID>
  </reference>
  <reference>
    <citation>Hohne C. Postoperative nausea and vomiting in pediatric anesthesia. Curr Opin Anaesthesiol. 2014 Jun;27(3):303-8. doi: 10.1097/ACO.0000000000000073.</citation>
    <PMID>24722005</PMID>
  </reference>
  <reference>
    <citation>Liversidge XL, Taylor DM, Liu B, Ling SL, Taylor SE. Variables associated with parent satisfaction with their child's pain management. Emerg Med Australas. 2016 Feb;28(1):39-43. doi: 10.1111/1742-6723.12519. Epub 2015 Dec 20.</citation>
    <PMID>26685807</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>December 30, 2019</last_update_submitted>
  <last_update_submitted_qc>December 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Mohammad Hazem I. Ahmad Sabry</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia/Head of Ambulatory surgery and pain clinic.</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/NCT03811392
org study id: 050108018(18/12/2018)
nct id: NCT03811392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing
      postoperative pain, opioid consumption, and recovery time following elective inguinal
      herniorraphy.

      The primary outcome:

      • to compare between caudal block and ultrasound guided quadratus lamborum block.

      The secondary outcome:

        -  duration of postoperative analgesia.

        -  incidence of postoperative complications.
After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed
      consent from the guardians of each patient, the present study will be carried out in
      Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society
      of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective
      inguinal herniorraphy in a randomized double blinded study.

      The sample size was calculated by High Institute of Public Health.

      Exclusion Criteria:

      Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or
      bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal

      The patients will be randomly divided by closed envelope technique into two groups:

      Group I: 30 patients will receive a caudal block after induction of general anaesthesia.

      Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior
      transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL
      muscles and the thoracolumbar fascia. .

      METHOD

      Preoperative Assessment:

        1. History taking

        2. Clinical examination

        3. Routine laboratory investigations including complete blood picture, bleeding and
           clotting time, prothrombin time, partial thromboplastin time, blood urea, serum
           creatinine and fasting blood sugar will be done to every patient.

      Pre anaesthetic preparation and premedication

        -  Nothing per mouth for 6 hours before surgery.

        -  A peripheral cannula (22 G) will be inserted in all patients.

        -  Administration 0f 10ml/kg. lactated Ringer's solution.

        -  All patients will be premedicated with atropine 0,1mg/kg. administered IM to all the
           patients 30 min prior to surgery.

      A multi-channel monitor will be attached to the patient to display:

        1. Continuous lead II electro cardiogram (ECG) monitoring.

        2. Non-invasive blood pressure measurement (NIBP) mmHg.

        3. Arterial oxygen saturation by pulse oximeter (SpO2%).

        4. End-tidal capnogram (ETco2).

      Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in
      oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a
      laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained
      with sevoflurane 2% and 50% air in oxygen.

        -  All procedures (Caudal , QL) will be performed by the same anaesthetist after placement
           of the LMA before surgery.

        -  The patients of both groups were admitted to the ward and receive standard postoperative
           analgesic regimen composed of regular paracetamol 15mg./kg. every 8hours.

      According to the studied group, patients will receive after induction either Group I: caudal
      block. Group II: Quadratus lamborum block.

      Technique:

      -For the caudal block, the patients were first inducted by GA and then they were placed in
      the altered left lateral position. The block site, which was mainly at the sacral hiatus, was
      sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a
      23-gage short needle injection was used with the bevel towards the abdomen to puncture the
      sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have
      punctured, the needle was tilted more towards the skin surface and the needle was inserted
      2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid
      extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25%
      bupivacaine 1 ml/kg was infused. (8,9).

      In the QL block group, the probe will be placed anterior and superior to the iliac crest, and
      the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will
      be followed posterolaterally until the posterior border of the muscle will be identified.
      When the probe is tilted to the attachment site of both the internal abdominal oblique muscle
      and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar
      fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex
      needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle
      will be directed from anterolateral to posteromedial after making a negative aspiration test
      with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection.
      An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the
      thoracolumbar fascia(10).

      The operation will be planned to begin 7 to 10 minutes after the block is applied , and all
      patients will be operated on with a standardized technique.

      Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability )
      behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater
      ibuprofen 7mg/kg will be administered orally .

      Any complications occurring during the procedure will be recorded and treated :

        -  Hypotension : In childhood, hypotension can be considered significant when there is
           20-30% reduction from baseline in systolic blood pressure ( SBP ) (12) . Treated by
           administering fluid bolus(13) .

        -  Bradycardia : Defined as(14):

      < 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine .

      • Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) .

      MEASURMENTS:

      The following parameters will be measured for all patients:

        -  Pain levels will be assessed using a FLACC (Face, Legs ,Activity, Cry, Consolability)
           behavioral pain assessment scale postoperatively after recovery at 30minutes and at 1,
           2, 4, 6, 12, and24 hours by the nurses and a second anesthetist will be blinded to
           groupassignment in the recovery room and the surgical ward .

        -  Duration of analgesia measured by time from start of the block to the first request for
           analgesia .

        -  Total analgesic dose .

        -  Postoperative complications, such as hypotension, arrhythmia, bradycardia,, nausea, or
           vomiting .

        -  Parent satisfaction. Satisfaction levels of the parents will be given verbally as a
           level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the
           highest level at 10(16).

      A-Haemodynamics

        1. Heart rate (beats/minute) and rhythm.

        2. Non-invasive mean arterial blood pressure (MABP) in mm Hg. Timing

             -  Baseline: before the block.

             -  Just after the block.

             -  Every 5 min during surgery.

             -  Every 2 hour after surgery.

      B-Need for intraoperative rescue analgesia:

      Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the
      absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline
      values obtained just before surgical incision. An intraoperative increase in blood pressure
      (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a
      rescue opioid (fentanyl; 1mcg/kg).

      C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores
      were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving
      into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120
      min. post-surgery, the last pain scores were taken. The pain scores were taken when the
      patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was
      infused.

      D-Analgesic requirements

        -  Total dose of analgesics postoperative will be recorded

        -  Time of first analgesic dose given. E-Incidence of postoperative complications: e.g.:
           nausea , vomiting and respiratory depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Postoperative pain.
time frame: 24 hours
description: FLACC Scale from 0 to 10
arm group label: Hernioraphy/Caudal block
arm group type: Active Comparator
description: patients will receive a caudal block after induction of general anaesthesia.
arm group label: Hernioraphy/Quadratus Lumborum block
arm group type: Active Comparator
description: patients will receive ultrasound guided quadrates lumborum block (QL )
intervention type: Procedure
intervention name: Hernioraphy/Caudal block
description: 30 patients will receive a caudal block after induction of general anaesthesia
arm group label: Hernioraphy/Caudal block
intervention type: Procedure
intervention name: Hernioraphy/Quadratus Lumborum block
description: 30 patients will receive ultrasound guided quadrates lumborum block
arm group label: Hernioraphy/Quadratus Lumborum block
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
last name: Mohammad Hazem I Ahmad Sabry, MB,ChB MD
role: Principal Investigator
affiliation: Alexandria University
facility: 
country: Egypt
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PMID: 15886601
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PMID: 22630613
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PMID: 24249997
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PMID: 12791112
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PMID: 28759502
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PMID: 26685807
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Mohammad Hazem I. Ahmad Sabry
investigator title: Lecturer of Anesthesia/Head of Ambulatory surgery and pain clinic.
mesh term: Pain, Postoperative
sharing ipd: No