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/NCT05969561</url>
    </required_header>
    <id_info>
      <org_study_id>202211021RINB</org_study_id>
      <nct_id>NCT05969561</nct_id>
    </id_info>
    <brief_title>Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.</brief_title>
    <official_title>Ultrasound-Guided Femoral Nerve Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        In this prospective study, emergency physicians perform ultrasound-guided femoral nerve block&#xD;
        for patients with hip fractures. We compare the effectiveness of analgesia and patient&#xD;
        satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medication&#xD;
        in the emergency department. The primary outcome is the assessment of time to relief the pain&#xD;
        with fewer adverse effects and less rescue pain medication use. The secondary outcome is&#xD;
        patient satisfaction with pain management.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2023</start_date>
    <completion_date type="Anticipated">June 30, 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>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>a short time of pain relief</measure>
      <time_frame>2 hours</time_frame>
      <description>the reduction of pain score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse effects</measure>
      <time_frame>two hours</time_frame>
      <description>Any adverse effects of different pain medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>two hours</time_frame>
      <description>The difference of patient satisfaction between ultrasound-guided femoral nerve block and the liberal use of pain medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications of ultrasound-guided femoral nerve block</measure>
      <time_frame>two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge</time_frame>
      <description>Any complications of ultrasound-guided femoral nerve block</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hip Fractures</condition>
    <arm_group>
      <arm_group_label>Ultrasound-guided femoral nerve block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with hip fractures had underwent Ultrasound-guided femoral nerve block performed by emergency physicians.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The liberal use of pain medication</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients with hip fractures had given intravenous or intramuscular opioids or NSAID at the emergency department.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultrasound-guided femoral nerve block</intervention_name>
      <description>The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.</description>
      <arm_group_label>Ultrasound-guided femoral nerve block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intravenous or intramuscular pain medication</intervention_name>
      <description>Intravenous or intramuscular pain medication is given for patients with hip fracture.</description>
      <arm_group_label>The liberal use of pain medication</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 20-year-old with hip fractures&#xD;
  &#xD;
            -  Stay in the emergency department for at lease two hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hemodynamic unstable&#xD;
  &#xD;
            -  major trauma in addition to hip fractures&#xD;
  &#xD;
            -  the use of any pain management before the arrival of emergency department&#xD;
  &#xD;
            -  chronic opioid use&#xD;
  &#xD;
            -  inability to understood the numerical rating scale after instruction&#xD;
  &#xD;
            -  allergy to local anesthetics&#xD;
  &#xD;
            -  coagulopathy&#xD;
  &#xD;
            -  injection site infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>YILIN LEE</last_name>
      <phone>+886972655633</phone>
      <email>leeatntuh@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>NTUH Yunlin Branch</name>
        <address>
          <city>Douliu</city>
          <state>Yunlin County</state>
          <zip>640</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>YILIN LEE</last_name>
        <phone>+886972655633</phone>
        <email>leeatntuh@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ultrasound-guided femoral nerve block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05969561
  org study id: 202211021RINB
  nct id: NCT05969561
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this prospective study, emergency physicians perform ultrasound-guided femoral nerve block
        for patients with hip fractures. We compare the effectiveness of analgesia and patient
        satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medication
        in the emergency department. The primary outcome is the assessment of time to relief the pain
        with fewer adverse effects and less rescue pain medication use. The secondary outcome is
        patient satisfaction with pain management.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: a short time of pain relief
  time frame: 2 hours
  description: the reduction of pain score
  measure: Adverse effects
  time frame: two hours
  description: Any adverse effects of different pain medication
  measure: Patient satisfaction
  time frame: two hours
  description: The difference of patient satisfaction between ultrasound-guided femoral nerve block and the liberal use of pain medication
  measure: Complications of ultrasound-guided femoral nerve block
  time frame: two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge
  description: Any complications of ultrasound-guided femoral nerve block
  arm group label: Ultrasound-guided femoral nerve block
  arm group type: Active Comparator
  description: Patients with hip fractures had underwent Ultrasound-guided femoral nerve block performed by emergency physicians.
  arm group label: The liberal use of pain medication
  arm group type: Sham Comparator
  description: Patients with hip fractures had given intravenous or intramuscular opioids or NSAID at the emergency department.
  intervention type: Procedure
  intervention name: ultrasound-guided femoral nerve block
  description: The local analgesia is injected and infiltrated around the femoral nerve under ultrasound guidance.
  arm group label: Ultrasound-guided femoral nerve block
  intervention type: Drug
  intervention name: Intravenous or intramuscular pain medication
  description: Intravenous or intramuscular pain medication is given for patients with hip fracture.
  arm group label: The liberal use of pain medication
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: YILIN LEE
  phone: +886972655633
  email: leeatntuh@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Hip Fractures
  mesh term: Analgesics