<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/NCT01701414</url>
  </required_header>
  <id_info>
    <org_study_id>210423</org_study_id>
    <nct_id>NCT01701414</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures</brief_title>
  <acronym>FNB</acronym>
  <official_title>Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures: a Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if ultrasound guided femoral nerve blocks&#xD;
      (localized anesthesia in the upper thigh) provide effective pain relief in adult patients&#xD;
      with hip fractures in the emergency department and to determine if femoral nerve blocks can&#xD;
      then be used to reduce the use of injected analgesia (anesthesia), therefore also causing&#xD;
      fewer adverse effects associated with injected analgesia (such as bruising at the site of&#xD;
      injection).&#xD;
&#xD;
      100 patients with hip fractures will be enrolled in the study. Patients will be randomly&#xD;
      assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care&#xD;
      (SC), which is injected analgesia alone.&#xD;
&#xD;
      Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine&#xD;
      (a local anesthetic of long duration) injected into the front of the thigh, at the site of&#xD;
      pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so&#xD;
      that no neither the patient or the treating physician knows to which group the patient was&#xD;
      randomized. All blocks will be performed in the emergency department by an emergency&#xD;
      physician trained in the use of ultrasound and ultrasound guided nerve blocks.&#xD;
&#xD;
      Subjects will be asked to rate their pain on a numeric pain scale both before and after&#xD;
      intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in&#xD;
      the ER still). Additional data to be collected includes demographics, vital signs, and course&#xD;
      of treatment resulting from the ED visit.&#xD;
&#xD;
      Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly&#xD;
      decrease or eliminate the need for narcotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hip fractures are a significant cause of morbidity and mortality in the elderly. In the acute&#xD;
      setting, safe and effective pain control is of the utmost importance. At present, this is&#xD;
      typically achieved with the use of parenteral opioids. However in older individuals, who&#xD;
      often have other medical comorbidities, the use of narcotics for pain control must be&#xD;
      balanced with their potentially deleterious consequences: namely respiratory depression,&#xD;
      hypotension, and mental confusion. Both poor pain control and the use of opioid medications&#xD;
      have been associated with acute confusional states in the elderly. 1,2 Regional anesthesia&#xD;
      can possibly provide adjunctive or even alternative pain control that is both safe and&#xD;
      effective.Femoral nerve blocks, using local anesthetics, have been described as a method to&#xD;
      reduce pain and the requirement for systemic analgesia, specifically opioids. Prior research&#xD;
      has demonstrated feasibility and effective pain control of the femoral nerve block in the ED&#xD;
      setting. Bedside ultrasound (US) can be used to precisely visualize the femoral neurovascular&#xD;
      anatomy when performing a femoral nerve block and has distinct advantages when performing&#xD;
      this procedure in the ED setting.&#xD;
&#xD;
      Study Objectives The primary aim of this study is to determine the relative effectiveness of&#xD;
      ultrasound guided femoral nerve blocks in older adult patients with hip fractures in the&#xD;
      emergency department as compared with parenteral narcotics alone. A secondary aim of this&#xD;
      study is to determine if femoral nerve blocks reduce both the use of parenteral narcotics and&#xD;
      the incidence adverse effects associated with parenteral analgesia (delirium, hypotension,&#xD;
      respiratory depression) in hip fracture patients both in the emergency department and during&#xD;
      their hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting at Least One NRS Rating</measure>
    <time_frame>30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.</time_frame>
    <description>Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Femoral Neck Fractures</condition>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Standard Care (SC)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral Nerve Block (FNB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name &quot;3-in-1 femoral block&quot; is often used), providing maximum analgesia to the hip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Femoral nerve block: 25 mL of 0.5% bupivacaine</intervention_name>
    <description>25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.</description>
    <arm_group_label>Femoral Nerve Block (FNB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo: 3cc of 0.9% Normal Saline</intervention_name>
    <description>1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice</description>
    <arm_group_label>Standard Care (SC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Adults over age 55&#xD;
&#xD;
          -  Able to understand and give informed consent&#xD;
&#xD;
          -  Comfortable with the experimental protocol as outlined to them by the RA or physician&#xD;
             investigator&#xD;
&#xD;
          -  Have radiologically confirmed hip fractures: femoral head, femoral neck&#xD;
             intertrochanteric, or subtrochanteric femur fractures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Femoral artery grafts on the same side as the fracture&#xD;
&#xD;
          -  Extensive lower extremity trauma&#xD;
&#xD;
          -  Concurrent tibia-fibula fractures&#xD;
&#xD;
          -  Hypersensitivity to local anesthetics or morphine&#xD;
&#xD;
          -  Neurovascular injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Otto Liebmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesca Beaudoin, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2008</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>May 29, 2013</results_first_submitted>
  <results_first_submitted_qc>January 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 7, 2014</results_first_posted>
  <last_update_submitted>February 7, 2014</last_update_submitted>
  <last_update_submitted_qc>February 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Femur</keyword>
  <keyword>Hip</keyword>
  <keyword>Fracture</keyword>
  <keyword>Femoral neck</keyword>
  <keyword>Femoral head</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>
    <mesh_term>Femoral Neck Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Adult ER patients at Rhode Island Hospital were recruited during the course of their clinical care between January 2010 and January 2012.</recruitment_details>
      <pre_assignment_details>Patients were approached after being triaged into the ER system and arrival in a private room but before receiving pain medication for hip fracture. Patients who declined did so because their pain was not severe enough, or they chose not to participate or could not consent, or they were sensitive to morphine (a required component of the study).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Femoral Nerve Block (FNB)</title>
          <description>Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name &quot;3-in-1 femoral block&quot; is often used), providing maximum analgesia to the hip.&#xD;
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.</description>
        </group>
        <group group_id="P2">
          <title>Standard Care (SC)</title>
          <description>The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.&#xD;
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>It was determined that a sample size of 17 in each arm would provide 80% power to detect at least a 33% PID. Sample size was inflated by 10% to account for attrition, missing data, and protocol violations, for a total of 19 subjects in each arm.</population>
      <group_list>
        <group group_id="B1">
          <title>Femoral Nerve Block (FNB)</title>
          <description>Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name &quot;3-in-1 femoral block&quot; is often used), providing maximum analgesia to the hip.&#xD;
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.</description>
        </group>
        <group group_id="B2">
          <title>Standard Care (SC)</title>
          <description>The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.&#xD;
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting at Least One NRS Rating</title>
        <description>Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.</description>
        <time_frame>30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Femoral Nerve Block (FNB)</title>
            <description>Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name &quot;3-in-1 femoral block&quot; is often used), providing maximum analgesia to the hip.&#xD;
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care (SC)</title>
            <description>The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.&#xD;
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting at Least One NRS Rating</title>
          <description>Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Femoral Nerve Block (FNB)</title>
          <description>Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name &quot;3-in-1 femoral block&quot; is often used), providing maximum analgesia to the hip.&#xD;
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.</description>
        </group>
        <group group_id="E2">
          <title>Standard Care (SC)</title>
          <description>The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.&#xD;
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Francesca Beaudoin MD, MS</name_or_title>
      <organization>Dept of Emergency Medicine, Rhode Island Hospital</organization>
      <phone>401-444-2577</phone>
      <email>fbeaudoin@lifespan.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01701414
org study id: 210423
nct id: NCT01701414
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if ultrasound guided femoral nerve blocks
      (localized anesthesia in the upper thigh) provide effective pain relief in adult patients
      with hip fractures in the emergency department and to determine if femoral nerve blocks can
      then be used to reduce the use of injected analgesia (anesthesia), therefore also causing
      fewer adverse effects associated with injected analgesia (such as bruising at the site of
      injection).

      100 patients with hip fractures will be enrolled in the study. Patients will be randomly
      assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care
      (SC), which is injected analgesia alone.

      Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine
      (a local anesthetic of long duration) injected into the front of the thigh, at the site of
      pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so
      that no neither the patient or the treating physician knows to which group the patient was
      randomized. All blocks will be performed in the emergency department by an emergency
      physician trained in the use of ultrasound and ultrasound guided nerve blocks.

      Subjects will be asked to rate their pain on a numeric pain scale both before and after
      intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in
      the ER still). Additional data to be collected includes demographics, vital signs, and course
      of treatment resulting from the ED visit.

      Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly
      decrease or eliminate the need for narcotics.
Hip fractures are a significant cause of morbidity and mortality in the elderly. In the acute
      setting, safe and effective pain control is of the utmost importance. At present, this is
      typically achieved with the use of parenteral opioids. However in older individuals, who
      often have other medical comorbidities, the use of narcotics for pain control must be
      balanced with their potentially deleterious consequences: namely respiratory depression,
      hypotension, and mental confusion. Both poor pain control and the use of opioid medications
      have been associated with acute confusional states in the elderly. 1,2 Regional anesthesia
      can possibly provide adjunctive or even alternative pain control that is both safe and
      effective.Femoral nerve blocks, using local anesthetics, have been described as a method to
      reduce pain and the requirement for systemic analgesia, specifically opioids. Prior research
      has demonstrated feasibility and effective pain control of the femoral nerve block in the ED
      setting. Bedside ultrasound (US) can be used to precisely visualize the femoral neurovascular
      anatomy when performing a femoral nerve block and has distinct advantages when performing
      this procedure in the ED setting.

      Study Objectives The primary aim of this study is to determine the relative effectiveness of
      ultrasound guided femoral nerve blocks in older adult patients with hip fractures in the
      emergency department as compared with parenteral narcotics alone. A secondary aim of this
      study is to determine if femoral nerve blocks reduce both the use of parenteral narcotics and
      the incidence adverse effects associated with parenteral analgesia (delirium, hypotension,
      respiratory depression) in hip fracture patients both in the emergency department and during
      their hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants Reporting at Least One NRS Rating
time frame: 30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.
description: Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.
arm group label: Standard Care (SC)
arm group type: Sham Comparator
description: The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
arm group label: Femoral Nerve Block (FNB)
arm group type: Experimental
description: Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name "3-in-1 femoral block" is often used), providing maximum analgesia to the hip.
intervention type: Drug
intervention name: Femoral nerve block: 25 mL of 0.5% bupivacaine
description: 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.
arm group label: Femoral Nerve Block (FNB)
intervention type: Drug
intervention name: Placebo: 3cc of 0.9% Normal Saline
description: 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice
arm group label: Standard Care (SC)
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Otto Liebmann, MD
role: Principal Investigator
affiliation: Rhode Island Hospital
last name: Francesca Beaudoin, MD, MS
role: Principal Investigator
affiliation: Rhode Island Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Femoral Neck Fractures
mesh term: Bupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 