<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/NCT02248870</url>
  </required_header>
  <id_info>
    <org_study_id>protocol1tdn</org_study_id>
    <nct_id>NCT02248870</nct_id>
  </id_info>
  <brief_title>Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture</brief_title>
  <official_title>Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24&#xD;
      hours in patients with hip fracture would have a major impact in order to provide better&#xD;
      preoperative analgesia for this group.&#xD;
&#xD;
      In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone&#xD;
      to the local anesthetics doubled the analgesic duration. No studies has investigated the&#xD;
      effect of the addition of Dexamethasone to the femoral nerve block in patients with hip&#xD;
      fracture.&#xD;
&#xD;
      The aim of our study is to investigate if more patients with hip fracture experience lasting&#xD;
      preoperative analgesia until the time of operation or 20 hours after a femoral nerve block&#xD;
      with the addition of Dexamethasone compared to the same nerve block done without&#xD;
      Dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with hip fractures are most often old, have multiple comorbidities and suffer severe&#xD;
      pain.&#xD;
&#xD;
      Femoral nerve block as a means of preoperative analgesia for these patients has proven&#xD;
      effective in multiple trials for the majority of the patients. Still some issues remains to&#xD;
      be investigated in order to optimize the preoperative analgesia for this group.&#xD;
&#xD;
      One of the issues that reduces the feasibility of the femoral nerve block is the relatively&#xD;
      shorter analgesic duration of the nerve block compared to the often longer time from the&#xD;
      hospital admission to the actual operation. From the literature and our own experience the&#xD;
      mean analgesic duration of a femoral nerve block approximates 15 hours.&#xD;
&#xD;
      Many studies have shown a prolonged analgesic duration of different nerve blocks when&#xD;
      Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in&#xD;
      duration.&#xD;
&#xD;
      To our knowledge no studies have been published regarding prolongation of the analgesic&#xD;
      effect of the femoral nerve block with Dexamethasone, and also none regarding the group of&#xD;
      patients with hip fracture.&#xD;
&#xD;
      The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared&#xD;
      to the present 15 hours would be less patients waking up in wards during the night time with&#xD;
      pain and a terminated femoral nerve block.&#xD;
&#xD;
      The purpose of this study is to investigate if more patients with hip fracture experience a&#xD;
      lasting preoperative analgesic duration of at least 20 hours or until the time of operation&#xD;
      after a femoral nerve block with Bupivacaine with adrenaline and the addition of&#xD;
      Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Less inclusions than expected with the given criteria&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of analgesia at the time of operation or at 20 hours</measure>
    <time_frame>Until the start of the operation or at 20 hours, average 18 hours</time_frame>
    <description>Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of analgesia at the time of operation or at 22 hours</measure>
    <time_frame>Until the start of the operation or at 22 hours, average 20 hours</time_frame>
    <description>Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of analgesia at the time of operation or at 24 hours</measure>
    <time_frame>Until the start of the operation or at 24 hours, average 22 hours</time_frame>
    <description>Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of satisfactory analgesia</measure>
    <time_frame>Until the start of the operation or at 20 hours, average 18 hours</time_frame>
    <description>Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to wish for opioid analgesia</measure>
    <time_frame>Until the start of the operation or at 24 hours, average 22 hours</time_frame>
    <description>Mean time fra nerve block to wish for opioid analgesia compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of opioid analgesia until 20 hours</measure>
    <time_frame>Until the start of the operation or at 20 hours, average 18 hours</time_frame>
    <description>Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of opioid analgesia until 22 hours</measure>
    <time_frame>Until the start of the operation or at 22 hours, average 20 hours</time_frame>
    <description>Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of opioid analgesia until 24 hours</measure>
    <time_frame>Until the start of the operation or at 24 hours, average 22 hours</time_frame>
    <description>Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to analgesic effect with patient at rest</measure>
    <time_frame>30 minutes</time_frame>
    <description>Mean time from nerve block to verbal pain score ≤3 at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to analgesic effect measured while doing passive leg raise</measure>
    <time_frame>30 minutes</time_frame>
    <description>Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of insufficient analgesia</measure>
    <time_frame>30 minutes</time_frame>
    <description>Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of absent analgesia</measure>
    <time_frame>30 minutes</time_frame>
    <description>Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients without sufficient analgesia</measure>
    <time_frame>30 minutes</time_frame>
    <description>Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin sensation in saphenous area</measure>
    <time_frame>30 minutes</time_frame>
    <description>Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin sensation in area of the anterior cutaneous branches of the femoral nerve</measure>
    <time_frame>30 minutes</time_frame>
    <description>Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sufficient analgesia Dexamethasone vs. plain</measure>
    <time_frame>30 minutes</time_frame>
    <description>Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nerve visualization</measure>
    <time_frame>Just before injection, which is within an expected average of 10 minutes after inclusion</time_frame>
    <description>Frequency of possible ultrasound visualization of the femoral nerve</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Hip Fracture</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Bupivacaine with adrenaline with 2 ml. of Saline added</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine with adrenaline with 2 ml. of Dexamethasone added</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection</description>
    <arm_group_label>Saline</arm_group_label>
    <other_name>Solution of sodium chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical suspicion of hip fracture&#xD;
&#xD;
          -  Age ≥ 55 years&#xD;
&#xD;
          -  Mentally capable of comprehending and using verbal pain score&#xD;
&#xD;
          -  Mentally capable of differentiating between pain from the fractured hip and pain from&#xD;
             other locations&#xD;
&#xD;
          -  Mentally capable of understanding the given information&#xD;
&#xD;
          -  Arrival in the emergency room at times when one of the doctors who do the nerve blocks&#xD;
             for this investigation are on call&#xD;
&#xD;
          -  Verbal pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time&#xD;
             of inclusion&#xD;
&#xD;
          -  Patients informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hip fracture not confirmed by x-ray&#xD;
&#xD;
          -  Weight &lt; 40 kg&#xD;
&#xD;
          -  Verbal pain score &gt; 3, 30 minutes after the nerve block&#xD;
&#xD;
          -  Verbal pain score &gt; 5 with passive leg raise, 30 minutes after the nerve block&#xD;
&#xD;
          -  Patient has previously been included in this trial&#xD;
&#xD;
          -  Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone&#xD;
&#xD;
          -  Verbal pain score &gt; 3 from other locations than the fractured hip&#xD;
&#xD;
          -  If the patient wishes to be excluded&#xD;
&#xD;
          -  Allergy to local anesthetics or adrenocortical hormone&#xD;
&#xD;
          -  Visible infection in the area of the point of needle injection&#xD;
&#xD;
          -  Acute inability to comprehend and use verbal pain score&#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>Thomas F. Bendtsen, MD, Ph.d.</last_name>
    <role>Study Director</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 11, 2015</last_update_submitted>
  <last_update_submitted_qc>September 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoral neck</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>Dexamethasone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02248870
org study id: protocol1tdn
nct id: NCT02248870
lead sponsor: 
has dmc: Yes
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24
      hours in patients with hip fracture would have a major impact in order to provide better
      preoperative analgesia for this group.

      In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone
      to the local anesthetics doubled the analgesic duration. No studies has investigated the
      effect of the addition of Dexamethasone to the femoral nerve block in patients with hip
      fracture.

      The aim of our study is to investigate if more patients with hip fracture experience lasting
      preoperative analgesia until the time of operation or 20 hours after a femoral nerve block
      with the addition of Dexamethasone compared to the same nerve block done without
      Dexamethasone.
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe
      pain.

      Femoral nerve block as a means of preoperative analgesia for these patients has proven
      effective in multiple trials for the majority of the patients. Still some issues remains to
      be investigated in order to optimize the preoperative analgesia for this group.

      One of the issues that reduces the feasibility of the femoral nerve block is the relatively
      shorter analgesic duration of the nerve block compared to the often longer time from the
      hospital admission to the actual operation. From the literature and our own experience the
      mean analgesic duration of a femoral nerve block approximates 15 hours.

      Many studies have shown a prolonged analgesic duration of different nerve blocks when
      Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in
      duration.

      To our knowledge no studies have been published regarding prolongation of the analgesic
      effect of the femoral nerve block with Dexamethasone, and also none regarding the group of
      patients with hip fracture.

      The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared
      to the present 15 hours would be less patients waking up in wards during the night time with
      pain and a terminated femoral nerve block.

      The purpose of this study is to investigate if more patients with hip fracture experience a
      lasting preoperative analgesic duration of at least 20 hours or until the time of operation
      after a femoral nerve block with Bupivacaine with adrenaline and the addition of
      Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency of analgesia at the time of operation or at 20 hours
time frame: Until the start of the operation or at 20 hours, average 18 hours
description: Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
measure: Frequency of analgesia at the time of operation or at 22 hours
time frame: Until the start of the operation or at 22 hours, average 20 hours
description: Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
measure: Frequency of analgesia at the time of operation or at 24 hours
time frame: Until the start of the operation or at 24 hours, average 22 hours
description: Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
measure: Frequency of satisfactory analgesia
time frame: Until the start of the operation or at 20 hours, average 18 hours
description: Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups
measure: Time to wish for opioid analgesia
time frame: Until the start of the operation or at 24 hours, average 22 hours
description: Mean time fra nerve block to wish for opioid analgesia compared between groups
measure: Use of opioid analgesia until 20 hours
time frame: Until the start of the operation or at 20 hours, average 18 hours
description: Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
measure: Use of opioid analgesia until 22 hours
time frame: Until the start of the operation or at 22 hours, average 20 hours
description: Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
measure: Use of opioid analgesia until 24 hours
time frame: Until the start of the operation or at 24 hours, average 22 hours
description: Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups
measure: Time to analgesic effect with patient at rest
time frame: 30 minutes
description: Mean time from nerve block to verbal pain score ≤3 at rest
measure: Time to analgesic effect measured while doing passive leg raise
time frame: 30 minutes
description: Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
measure: Frequency of insufficient analgesia
time frame: 30 minutes
description: Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
measure: Frequency of absent analgesia
time frame: 30 minutes
description: Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
measure: Frequency of patients without sufficient analgesia
time frame: 30 minutes
description: Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
measure: Skin sensation in saphenous area
time frame: 30 minutes
description: Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
measure: Skin sensation in area of the anterior cutaneous branches of the femoral nerve
time frame: 30 minutes
description: Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
measure: Sufficient analgesia Dexamethasone vs. plain
time frame: 30 minutes
description: Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
measure: Nerve visualization
time frame: Just before injection, which is within an expected average of 10 minutes after inclusion
description: Frequency of possible ultrasound visualization of the femoral nerve
arm group label: Saline
arm group type: Placebo Comparator
description: Bupivacaine with adrenaline with 2 ml. of Saline added
arm group label: Dexamethasone
arm group type: Experimental
description: Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
arm group label: Dexamethasone
intervention type: Drug
intervention name: Saline
description: Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
arm group label: Saline
other name: Solution of sodium chloride
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas F. Bendtsen, MD, Ph.d.
role: Study Director
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Dexamethasone