<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/NCT04470115</url>
  </required_header>
  <id_info>
    <org_study_id>01_2019</org_study_id>
    <nct_id>NCT04470115</nct_id>
  </id_info>
  <brief_title>Blocks for Intertrochanteric Fracture Repair Surgery</brief_title>
  <official_title>Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Institute od Medicine National Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Institute od Medicine National Research Institute</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>
      This single-center open label study compares the outcomes of surgical repair of&#xD;
      intratrochanteric fracture under general anesthetic or peripheral nerve blocks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-center open label study compares the outcomes of surgical repair of&#xD;
      intratrochanteric fracture under general anesthetic or peripheral nerve blocks.&#xD;
&#xD;
      Patients are high risk individuals scheduled for intratrochanteric fracture repair, with&#xD;
      contraindications to spinal anesthesia. One group will receive general endotracheal&#xD;
      anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.&#xD;
&#xD;
      Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and&#xD;
      opioid consumption will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients surviving 30 days after the surgery.</measure>
    <time_frame>30 days from the day of the surgery.</time_frame>
    <description>Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.</measure>
    <time_frame>30 days from the day of the surgery.</time_frame>
    <description>Occurence of stroke or acute coronary syndrome will be assessed during period of 30 postoperative days. The result will be displayed as a percentage of examined group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients suffering from postoperative delirium during 7 days after the surgery.</measure>
    <time_frame>7 days after the surgery.</time_frame>
    <description>Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score after surgery</measure>
    <time_frame>first 24 hours after surgery</time_frame>
    <description>Patients will be asked about their pain ranks 6 and 24 hours after surgery. The NRS score will be used (0 to 10) where 0 is no pain and 10 is extremely severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>first 24 hours after surgery</time_frame>
    <description>Opioid (eg morphine) consumption will be noted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intertrochanteric Fractures</condition>
  <arm_group>
    <arm_group_label>General anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regional anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive femoral and lateral femoral cutaneous nerves block under ultrasonographical guidance before operation.During surgical procedure they will receive deep sedation with propofol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>Patients will receive general endotracheal anesthesia with typical drugs used (propofol, fentanyl, sevoflurane). the exact dose of the drug will be on the discretion of anesthesia provider, according to good clinical practice.</description>
    <arm_group_label>General anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks</intervention_name>
    <description>The femoral nerve (FN) is identified with ultrasound. The needle is inserted in-plane, from lateral to medial. We administer 15 to 17ml of local anesthetic (0.5 to 0.75% ropivacaine). After good anesthetic spread on FN we identify lateral femoral cutaneous nerve (LFCN) in its expected location 2-3 cm below inguinal ligament, laterally to sartorius muscle and inject usually 4 to 5 ml of local anesthetic. Oxygen 2-3 l/min is given via face mask to maintain Sp02 and the block is followed by sedation. Sedation is achieved with boluses of propofol to enable procedure and maintain patient in comfort. We aim to keep the depth of sedation at Ramsay sedation scale of 4. Whether it is possible we use loud verbal stimulus, if it is not we use gently glabella tap to assess depth of sedation. Patient is breathing spontaneously during the whole surgery. After surgical field is prepared, surgeon infiltrates expected entry points of intramedullary nail system with 0,5% lidocaine.</description>
    <arm_group_label>Regional anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intratrochanteric fracture&#xD;
&#xD;
          -  need for surgery&#xD;
&#xD;
          -  contraindications for spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jakub Klimkiewicz, MD, PhD</last_name>
    <phone>0048261816896</phone>
    <email>jklimkiewicz@wim.mil.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mateusz Gutowski, MD</last_name>
    <phone>0048261816896</phone>
    <email>mgutowski@wim.mil.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Military Institute of Medicine</name>
      <address>
        <city>Warsaw</city>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jakub Klimkiewicz, MD, PhD</last_name>
      <phone>0048261816896</phone>
      <email>jklimkiewicz@wim.mil.pl</email>
    </contact>
    <contact_backup>
      <last_name>Mateusz Gutowski, MD</last_name>
      <phone>0048261816896</phone>
      <email>mgutowski@wim.mil.pl</email>
    </contact_backup>
    <investigator>
      <last_name>Jakub Klimkiewicz, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mateusz Gutowski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bartosz Rustecki, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dymitr Kochanowski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna Klimkiewicz, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Institute od Medicine National Research Institute</investigator_affiliation>
    <investigator_full_name>Jakub Klimkiewicz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>intratrochanteric fracture</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>femoral nerve block</keyword>
  <keyword>lateral femoral cutaneous nerve block</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT04470115
org study id: 01_2019
nct id: NCT04470115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single-center open label study compares the outcomes of surgical repair of
      intratrochanteric fracture under general anesthetic or peripheral nerve blocks.
This single-center open label study compares the outcomes of surgical repair of
      intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

      Patients are high risk individuals scheduled for intratrochanteric fracture repair, with
      contraindications to spinal anesthesia. One group will receive general endotracheal
      anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.

      Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and
      opioid consumption will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients surviving 30 days after the surgery.
time frame: 30 days from the day of the surgery.
description: Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.
measure: Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
time frame: 30 days from the day of the surgery.
description: Occurence of stroke or acute coronary syndrome will be assessed during period of 30 postoperative days. The result will be displayed as a percentage of examined group.
measure: Percentage of patients suffering from postoperative delirium during 7 days after the surgery.
time frame: 7 days after the surgery.
description: Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.
measure: Pain score after surgery
time frame: first 24 hours after surgery
description: Patients will be asked about their pain ranks 6 and 24 hours after surgery. The NRS score will be used (0 to 10) where 0 is no pain and 10 is extremely severe pain.
measure: Opioid consumption
time frame: first 24 hours after surgery
description: Opioid (eg morphine) consumption will be noted
arm group label: General anesthesia
arm group type: Active Comparator
description: Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.
arm group label: Regional anesthesia
arm group type: Experimental
description: Patients will receive femoral and lateral femoral cutaneous nerves block under ultrasonographical guidance before operation.During surgical procedure they will receive deep sedation with propofol.
intervention type: Other
intervention name: General anesthesia
description: Patients will receive general endotracheal anesthesia with typical drugs used (propofol, fentanyl, sevoflurane). the exact dose of the drug will be on the discretion of anesthesia provider, according to good clinical practice.
arm group label: General anesthesia
intervention type: Other
intervention name: Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks
description: The femoral nerve (FN) is identified with ultrasound. The needle is inserted in-plane, from lateral to medial. We administer 15 to 17ml of local anesthetic (0.5 to 0.75% ropivacaine). After good anesthetic spread on FN we identify lateral femoral cutaneous nerve (LFCN) in its expected location 2-3 cm below inguinal ligament, laterally to sartorius muscle and inject usually 4 to 5 ml of local anesthetic. Oxygen 2-3 l/min is given via face mask to maintain Sp02 and the block is followed by sedation. Sedation is achieved with boluses of propofol to enable procedure and maintain patient in comfort. We aim to keep the depth of sedation at Ramsay sedation scale of 4. Whether it is possible we use loud verbal stimulus, if it is not we use gently glabella tap to assess depth of sedation. Patient is breathing spontaneously during the whole surgery. After surgical field is prepared, surgeon infiltrates expected entry points of intramedullary nail system with 0,5% lidocaine.
arm group label: Regional anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jakub Klimkiewicz, MD, PhD
phone: 0048261816896
email: jklimkiewicz@wim.mil.pl
last name: Mateusz Gutowski, MD
phone: 0048261816896
email: mgutowski@wim.mil.pl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Military Institute od Medicine National Research Institute
investigator full name: Jakub Klimkiewicz
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Anesthetics
sharing ipd: No