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/NCT05987254</url>
    </required_header>
    <id_info>
      <org_study_id>RC 11-3-2023</org_study_id>
      <nct_id>NCT05987254</nct_id>
    </id_info>
    <brief_title>Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients</brief_title>
    <official_title>Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Benha University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Al-Azhar 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>
        Severe pain associated with fractured hip often results in difficulty during positioning for&#xD;
        spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca&#xD;
        compartment block (FICB) is popular among anesthesiologists to provide immediate as well as&#xD;
        postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block&#xD;
        has been proposed to provide effective analgesia in hip fracture patients. However,&#xD;
        comparative studies between PENG and FICB are lacking.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>NRS</measure>
      <time_frame>30 minute postoperative</time_frame>
      <description>In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>amount of tramadol used</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>number of rescue doses of tramadol will be recorded</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Spinal Anesthesia</condition>
    <condition>Hip Fractures</condition>
    <arm_group>
      <arm_group_label>FICB group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received ultrasound guided suprainguinal fascia iliaca block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PENG group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received ultrasound guided pericapsular nerve group block</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>suprainguinal fascia iliaca block</intervention_name>
      <description>ultrasound guided suprainguinal fascia iliaca block</description>
      <arm_group_label>FICB group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pericapsular nerve group block</intervention_name>
      <description>ultrasound guided pericapsular nerve group block</description>
      <arm_group_label>PENG group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  40 years and above with hip fracture with persistent pain and scheduled for surgery&#xD;
               under spinal anesthesia (SA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any contraindications to SA or peripheral nerve blocks, history of ischaemic heart&#xD;
               disease, patients on opioids for chronic pain and patients with significant cognitive&#xD;
               impairment. Patients who had no pain while sitting by themselves (resting pain less&#xD;
               than 4 on NRS) for SA without any support were also excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Haney Baumey</name>
        <address>
          <city>Banhā</city>
          <zip>13518</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Facualty of Pharmacy, Al Azhar University</name>
        <address>
          <city>Cairo</city>
          <zip>11765</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Neveen Abd El Maksoad Kohaf</investigator_full_name>
      <investigator_title>Lecturer of Clinical Pharmacy</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>data will be shared upon resealable request from the principal investigator</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </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/NCT05987254
  org study id: RC 11-3-2023
  nct id: NCT05987254
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Severe pain associated with fractured hip often results in difficulty during positioning for
        spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca
        compartment block (FICB) is popular among anesthesiologists to provide immediate as well as
        postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block
        has been proposed to provide effective analgesia in hip fracture patients. However,
        comparative studies between PENG and FICB are lacking.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: NRS
  time frame: 30 minute postoperative
  description: In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
  measure: amount of tramadol used
  time frame: 24 hours postoperatively
  description: number of rescue doses of tramadol will be recorded
  arm group label: FICB group
  arm group type: Active Comparator
  description: received ultrasound guided suprainguinal fascia iliaca block
  arm group label: PENG group
  arm group type: Active Comparator
  description: received ultrasound guided pericapsular nerve group block
  intervention type: Procedure
  intervention name: suprainguinal fascia iliaca block
  description: ultrasound guided suprainguinal fascia iliaca block
  arm group label: FICB group
  intervention type: Procedure
  intervention name: pericapsular nerve group block
  description: ultrasound guided pericapsular nerve group block
  arm group label: PENG group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Neveen Abd El Maksoad Kohaf
  investigator title: Lecturer of Clinical Pharmacy
  mesh term: Fractures, Bone
  mesh term: Hip Fractures
  sharing ipd: Yes
  ipd description: data will be shared upon resealable request from the principal investigator
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)