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/NCT05981781</url>
    </required_header>
    <id_info>
      <org_study_id>0107623</org_study_id>
      <nct_id>NCT05981781</nct_id>
    </id_info>
    <brief_title>Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery</brief_title>
    <official_title>Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG&#xD;
        block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in&#xD;
        paediatrics&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hip surgeries in paediatric patients such as open hip surgery for correction of developmental&#xD;
        dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia&#xD;
        is required to provide intraoperative and postoperative analgesia and to prevent the&#xD;
        undesirable side effects of opioids including sedation, nausea, vomiting and constipation.&#xD;
  &#xD;
        Perioperative pain control is of paramount importance during paediatric hip surgery.&#xD;
        Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged&#xD;
        recovery, and increased length of hospital stay. As such, regional anaesthesia is&#xD;
        advantageous in providing sufficient analgesia while reducing the adverse effects of opioids.&#xD;
        The use of regional anaesthesia in the paediatric population has increased over the last&#xD;
        decade as it offers several potential advantages in the provision of postoperative analgesia&#xD;
        including a reduction in parenteral opioids, decreased exposure to general anaesthetic&#xD;
        agents, and shortened hospital stay. Such techniques may be particularly valuable following&#xD;
        painful orthopedic procedures including hip and femur surgery.&#xD;
  &#xD;
        Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral&#xD;
        nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit&#xD;
        opioid-sparing effects and lower postoperative pain scores in patients who are suffering from&#xD;
        hip pain.&#xD;
  &#xD;
        Caudal block is a common technique used for perioperative pain relief in paediatric lower&#xD;
        limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain&#xD;
        scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral&#xD;
        sensory and motor blockade, and urinary retention limit their use.&#xD;
  &#xD;
        Among peripheral nerve block techniques used for relieving pain associated with hip fracture,&#xD;
        ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1&#xD;
        FN block are widely used. However, these techniques have often failed to provide adequate&#xD;
        block of the obturator nerve (ON) and the accessory obturator nerve (AON).&#xD;
  &#xD;
        The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described&#xD;
        by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the&#xD;
        femoral, obturator and accessory obturator nerves that provide sensory innervation to the&#xD;
        anterior hip capsule. It is a plane block involving one injection, performed under ultrasound&#xD;
        guidance, of a high volume of local anaesthetic into the musculofascial plane between the&#xD;
        psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular&#xD;
        branches of ON were blocked successfully due to the proximity of the target area to the&#xD;
        subpectineal plane.&#xD;
  &#xD;
        PENG block has been initially used as an alternative regional anaesthetic technique for the&#xD;
        management of acute pain after hip fracture , but its applications are expanding, suggesting&#xD;
        a potential role for analgesia after elective hip surgery. Previous studies concluded that&#xD;
        this technique could provide an effective blockade of the articular branches of FN, ON and&#xD;
        AON, with a potential motor-sparing effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Double blinded randomized study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
      <masking_description>the patients , outcome assessors and care providers are not informed with the block type done.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative opioid consumption</measure>
      <time_frame>24 hours</time_frame>
      <description>compare between both groups as regard postoperative opioid consumption</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative analgesia</measure>
      <time_frame>24 hours</time_frame>
      <description>postoperative analgesia by using FLACC scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>duration of postoperative analgesia</measure>
      <time_frame>24 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heamodynamics</measure>
      <time_frame>24 hours</time_frame>
      <description>changes in heart rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of complications</measure>
      <time_frame>24 hours</time_frame>
      <description>hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>parent satisfaction</measure>
      <time_frame>24 hours</time_frame>
      <description>Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>heamodynamics</measure>
      <time_frame>24 hours</time_frame>
      <description>Changes in arterial blood pressure</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Postoperative Pain in Paediatric Hip Surgery</condition>
    <condition>PENG Block</condition>
    <condition>Caudal Block</condition>
    <arm_group>
      <arm_group_label>ultrasound guided peng block in paediatric hip surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ultrasound guided caudal epidural block in paediatric hip surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultrasound guided peng block in paediatric hip surgery</intervention_name>
      <description>On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus.&#xD;
  Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.</description>
      <arm_group_label>ultrasound guided peng block in paediatric hip surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultrasound guided caudal epidural block in paediatric hip surgery</intervention_name>
      <description>On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.</description>
      <arm_group_label>ultrasound guided caudal epidural block in paediatric hip surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  paediatric patients belonging to American society of anesthesiologists (ASA)class1 or&#xD;
               2, aged 2-8 years scheduled for hip surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  parent refusal skin infection at site of injection bleeding disorder or receiving&#xD;
               anticoagulants history of allergy or contraindicaion to local anaesthetics&#xD;
               neurological disease as cerebral palsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rabab Saber, professor</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Aly Mahmoud, lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed Mansour, professor</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>yomna Said, MBBCH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yomna Said, MBBCH</last_name>
      <phone>01065677956</phone>
      <email>yomna.said7@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine</name>
        <address>
          <city>Alexandria</city>
          <state>Alexandria, Egypt</state>
          <zip>21111</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PENG block</keyword>
    <keyword>caudal block</keyword>
    <keyword>hip surgery</keyword>
    <keyword>postoperative pain</keyword>
    <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>Yes</sharing_ipd>
      <ipd_description>Data results and statistical analysis</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>before the start till publishing the study</ipd_time_frame>
      <ipd_access_criteria>not public only researchers who can access study information</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05981781
  org study id: 0107623
  nct id: NCT05981781
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG
        block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in
        paediatrics
  Hip surgeries in paediatric patients such as open hip surgery for correction of developmental
        dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia
        is required to provide intraoperative and postoperative analgesia and to prevent the
        undesirable side effects of opioids including sedation, nausea, vomiting and constipation.
  
        Perioperative pain control is of paramount importance during paediatric hip surgery.
        Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged
        recovery, and increased length of hospital stay. As such, regional anaesthesia is
        advantageous in providing sufficient analgesia while reducing the adverse effects of opioids.
        The use of regional anaesthesia in the paediatric population has increased over the last
        decade as it offers several potential advantages in the provision of postoperative analgesia
        including a reduction in parenteral opioids, decreased exposure to general anaesthetic
        agents, and shortened hospital stay. Such techniques may be particularly valuable following
        painful orthopedic procedures including hip and femur surgery.
  
        Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral
        nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit
        opioid-sparing effects and lower postoperative pain scores in patients who are suffering from
        hip pain.
  
        Caudal block is a common technique used for perioperative pain relief in paediatric lower
        limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain
        scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral
        sensory and motor blockade, and urinary retention limit their use.
  
        Among peripheral nerve block techniques used for relieving pain associated with hip fracture,
        ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1
        FN block are widely used. However, these techniques have often failed to provide adequate
        block of the obturator nerve (ON) and the accessory obturator nerve (AON).
  
        The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described
        by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the
        femoral, obturator and accessory obturator nerves that provide sensory innervation to the
        anterior hip capsule. It is a plane block involving one injection, performed under ultrasound
        guidance, of a high volume of local anaesthetic into the musculofascial plane between the
        psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular
        branches of ON were blocked successfully due to the proximity of the target area to the
        subpectineal plane.
  
        PENG block has been initially used as an alternative regional anaesthetic technique for the
        management of acute pain after hip fracture , but its applications are expanding, suggesting
        a potential role for analgesia after elective hip surgery. Previous studies concluded that
        this technique could provide an effective blockade of the articular branches of FN, ON and
        AON, with a potential motor-sparing effect.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Double blinded randomized study
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  masking description: the patients , outcome assessors and care providers are not informed with the block type done.
  measure: postoperative opioid consumption
  time frame: 24 hours
  description: compare between both groups as regard postoperative opioid consumption
  measure: postoperative analgesia
  time frame: 24 hours
  description: postoperative analgesia by using FLACC scale
  measure: duration of postoperative analgesia
  time frame: 24 hours
  measure: heamodynamics
  time frame: 24 hours
  description: changes in heart rate
  measure: incidence of complications
  time frame: 24 hours
  description: hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis
  measure: parent satisfaction
  time frame: 24 hours
  description: Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)
  measure: heamodynamics
  time frame: 24 hours
  description: Changes in arterial blood pressure
  arm group label: ultrasound guided peng block in paediatric hip surgery
  arm group type: Active Comparator
  description: Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.
  arm group label: ultrasound guided caudal epidural block in paediatric hip surgery
  arm group type: Active Comparator
  description: Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.
  intervention type: Procedure
  intervention name: ultrasound guided peng block in paediatric hip surgery
  description: On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus.
  Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.
  arm group label: ultrasound guided peng block in paediatric hip surgery
  intervention type: Procedure
  intervention name: ultrasound guided caudal epidural block in paediatric hip surgery
  description: On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.
  arm group label: ultrasound guided caudal epidural block in paediatric hip surgery
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 8 Years
  healthy volunteers: No
  last name: Rabab Saber, professor
  role: Study Director
  affiliation: Alexandria University
  last name: Aly Mahmoud, lecturer
  role: Study Director
  affiliation: Alexandria University
  last name: Ahmed Mansour, professor
  role: Study Director
  affiliation: Alexandria University
  last name: yomna Said, MBBCH
  role: Principal Investigator
  affiliation: Alexandria University
  last name: Yomna Said, MBBCH
  phone: 01065677956
  email: yomna.said7@gmail.com
  facility: 
  status: Recruiting
  country: Egypt
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  sharing ipd: Yes
  ipd description: Data results and statistical analysis
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: before the start till publishing the study
  ipd access criteria: not public only researchers who can access study information