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/NCT06003738</url>
    </required_header>
    <id_info>
      <org_study_id>FMASU MD76/2023</org_study_id>
      <nct_id>NCT06003738</nct_id>
    </id_info>
    <brief_title>Comparing Postoperative Pain After Pericapsular Nerve Block and Fascia Iliaca Block in Total Hip Arthroplasty</brief_title>
    <official_title>A Comparative Study Between the Postoperative Analgesic Effect of Pericapsular Nerve Group Block (PENG) and Fascia Iliaca Compartment Block (FICB) in Total Hip Arthroplasty: a Prospective Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to investigate the efficiency of post-operative analgesia by fascia&#xD;
        iliaca compartment block versus pericapsular nerve group block block in reducing narcotic&#xD;
        consumption during the first 24 hour post-operatively by using the Visual Analogue Scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Total hip arthroplasty is a widely used surgical treatment intervention for treating hip&#xD;
        conditions such as femur neck fractures and advanced hip osteoarthritis.&#xD;
  &#xD;
        Hip fractures are quite common, regardless of the age of the population (young or old), and&#xD;
        they are extremely painful. A hip fracture is a serious injury with potentially&#xD;
        life-threatening complications, and it is a common orthopedic emergency in elderly&#xD;
        individuals. Early surgery within 48 hours of a fracture has been found to lower mortality&#xD;
        and complication rates.&#xD;
  &#xD;
        The pericapsular nerve group block is a novel regional analgesia technique to decrease pain&#xD;
        after THA while preserving the motor function. The local anaesthetic is deposited using this&#xD;
        method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims&#xD;
        sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior&#xD;
        capsule of the hip.&#xD;
  &#xD;
        Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a&#xD;
        well-liked regional anaesthetic technique. Studies have found that FICB prevents&#xD;
        complications by anaesthetizing the femoral nerve far from critical neurovascular structures&#xD;
        while still giving enough analgesia.&#xD;
  &#xD;
        Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid&#xD;
        consumption, and length of hospital stay in THA patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 21, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of the studied blocks on the Visual Analogue Scale for pain</measure>
      <time_frame>Immediately postoperatively (zero time)</time_frame>
      <description>the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the Visual Analogue Scale for pain</measure>
      <time_frame>Every 2 hours during the first 6 hours</time_frame>
      <description>the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the Visual Analogue Scale for pain</measure>
      <time_frame>every 6 hours in the first 24 hours postoperatively</time_frame>
      <description>the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The total dose of nalbuphine in mg was used postoperatively per patient</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>rescue analgesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean arterial blood pressure change</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>hemodynamics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate change</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>hemodynamics</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>The fascia iliaca compartment block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The first group 34 patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The pericapsular nerve block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The second group 34 patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>fascia iliaca compartment block</intervention_name>
      <description>Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle.&#xD;
  The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of 0.25% bupivacaine will be injected.</description>
      <arm_group_label>The fascia iliaca compartment block group</arm_group_label>
      <other_name>FICB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pericapsular nerve block</intervention_name>
      <description>The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of 0.25% bupivacaine will be injected .</description>
      <arm_group_label>The pericapsular nerve block group</arm_group_label>
      <other_name>PENG</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>palcebo fascia iliaca compartment block</intervention_name>
      <description>Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle.&#xD;
  The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of normal saline will be injected.</description>
      <arm_group_label>The pericapsular nerve block group</arm_group_label>
      <other_name>palcebo FICB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>palcebo pericapsular nerve block</intervention_name>
      <description>The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of normal saline will be injected .</description>
      <arm_group_label>The fascia iliaca compartment block group</arm_group_label>
      <other_name>palcebo PENG</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-80 years.&#xD;
  &#xD;
            2. Sex: Both sexes.&#xD;
  &#xD;
            3. American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.&#xD;
  &#xD;
            4. Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Declining to give a written informed consent.&#xD;
  &#xD;
            2. History of allergy to the medications used in the study.&#xD;
  &#xD;
            3. Contraindications to regional anesthesia (including patient refusal, coagulopathy, and&#xD;
               local infection).&#xD;
  &#xD;
            4. Psychiatric disorders.&#xD;
  &#xD;
            5. Significant cognitive dysfunction.&#xD;
  &#xD;
            6. American Society of Anesthesiologists (ASA) Physical Status Class IV.&#xD;
  &#xD;
            7. Liver failure, renal insufficiency (estimated glomerular filtration rate &lt; 15&#xD;
               mL/min/1.73 m2).&#xD;
  &#xD;
            8. Patients who had failed spinal anaesthesia were excluded from the study.&#xD;
  &#xD;
            9. Pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Diaaeldin DA Aboelnile, MD, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Medicine, Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Diaaeldin DA Aboelnile, MD, Lecturer</last_name>
      <phone>00201018380033</phone>
      <email>diaabadr@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ain shams university hospitals</name>
        <address>
          <city>Cairo</city>
          <zip>11588</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Diaaeldin BM Aboelnile, MD</last_name>
        <phone>2001018380033</phone>
        <email>diaabadr@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Diaaeldin Badr Aboelnile</investigator_full_name>
      <investigator_title>Lecturer of Anesthesia</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06003738
  org study id: FMASU MD76/2023
  nct id: NCT06003738
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the efficiency of post-operative analgesia by fascia
        iliaca compartment block versus pericapsular nerve group block block in reducing narcotic
        consumption during the first 24 hour post-operatively by using the Visual Analogue Scale.
  Total hip arthroplasty is a widely used surgical treatment intervention for treating hip
        conditions such as femur neck fractures and advanced hip osteoarthritis.
  
        Hip fractures are quite common, regardless of the age of the population (young or old), and
        they are extremely painful. A hip fracture is a serious injury with potentially
        life-threatening complications, and it is a common orthopedic emergency in elderly
        individuals. Early surgery within 48 hours of a fracture has been found to lower mortality
        and complication rates.
  
        The pericapsular nerve group block is a novel regional analgesia technique to decrease pain
        after THA while preserving the motor function. The local anaesthetic is deposited using this
        method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims
        sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior
        capsule of the hip.
  
        Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a
        well-liked regional anaesthetic technique. Studies have found that FICB prevents
        complications by anaesthetizing the femoral nerve far from critical neurovascular structures
        while still giving enough analgesia.
  
        Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid
        consumption, and length of hospital stay in THA patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: The effect of the studied blocks on the Visual Analogue Scale for pain
  time frame: Immediately postoperatively (zero time)
  description: the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain
  measure: Change in the Visual Analogue Scale for pain
  time frame: Every 2 hours during the first 6 hours
  description: the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain
  measure: Change in the Visual Analogue Scale for pain
  time frame: every 6 hours in the first 24 hours postoperatively
  description: the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain
  measure: The total dose of nalbuphine in mg was used postoperatively per patient
  time frame: 24 hours postoperatively
  description: rescue analgesia
  measure: Mean arterial blood pressure change
  time frame: 24 hours postoperatively
  description: hemodynamics
  measure: Heart rate change
  time frame: 24 hours postoperatively
  description: hemodynamics
  arm group label: The fascia iliaca compartment block group
  arm group type: Active Comparator
  description: The first group 34 patients
  arm group label: The pericapsular nerve block group
  arm group type: Active Comparator
  description: The second group 34 patients
  intervention type: Procedure
  intervention name: fascia iliaca compartment block
  description: Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle.
  The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of 0.25% bupivacaine will be injected.
  arm group label: The fascia iliaca compartment block group
  other name: FICB
  intervention type: Procedure
  intervention name: pericapsular nerve block
  description: The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of 0.25% bupivacaine will be injected .
  arm group label: The pericapsular nerve block group
  other name: PENG
  intervention type: Procedure
  intervention name: palcebo fascia iliaca compartment block
  description: Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle.
  The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of normal saline will be injected.
  arm group label: The pericapsular nerve block group
  other name: palcebo FICB
  intervention type: Procedure
  intervention name: palcebo pericapsular nerve block
  description: The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of normal saline will be injected .
  arm group label: The fascia iliaca compartment block group
  other name: palcebo PENG
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Diaaeldin DA Aboelnile, MD, Lecturer
  role: Principal Investigator
  affiliation: Faculty of Medicine, Ain Shams University
  last name: Diaaeldin DA Aboelnile, MD, Lecturer
  phone: 00201018380033
  email: diaabadr@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Diaaeldin Badr Aboelnile
  investigator title: Lecturer of Anesthesia
  sharing ipd: No