<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/NCT04454203</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00104144</org_study_id>
    <nct_id>NCT04454203</nct_id>
  </id_info>
  <brief_title>Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension</brief_title>
  <official_title>Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this prospective randomized double-blind study is to determine if an ultrasound&#xD;
      guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via&#xD;
      peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower&#xD;
      extremity tourniquet time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a research study to find out if injection of numbing medication by the large artery&#xD;
      going down your leg will improve high blood pressure caused by the tourniquet.&#xD;
&#xD;
      Depending on whether you enroll in this study, you may receive an injection of local&#xD;
      anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large&#xD;
      artery going down your leg). This is to see how this injection impacts your blood pressure&#xD;
      during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help&#xD;
      decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to&#xD;
      go up, but the numbing medication may help return your blood pressure close to its normal&#xD;
      level. The rest of your anesthesia care, including other nerve blocks and general anesthetic,&#xD;
      will be the same as it would be without participating in the study. You will be enrolled in&#xD;
      this study for 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 5, 2021</start_date>
  <completion_date type="Anticipated">May 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2025</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in tourniquet hypertension as measured by systolic blood pressure</measure>
    <time_frame>From time of injection to 30 minutes after injection</time_frame>
    <description>Infiltrating study drug to reverse intraoperative tourniquet hypertension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores (NRS11)</measure>
    <time_frame>Perioperative start until 2 hours after admission to PACU</time_frame>
    <description>The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Perioperative start until 2 hours after admission to PACU</time_frame>
    <description>Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps motor function</measure>
    <time_frame>1 hour after extubation</time_frame>
    <description>Gross quadriceps motor function as measured by leg extension</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Tourniquet Hypertension</condition>
  <condition>Intraoperative Hypertension</condition>
  <condition>Total Ankle Arthroplasty</condition>
  <condition>Ankle Fusion</condition>
  <arm_group>
    <arm_group_label>Mepivacaine Block Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Sham Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mepivacaine</intervention_name>
    <description>An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.</description>
    <arm_group_label>Mepivacaine Block Group</arm_group_label>
    <other_name>Carbocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>An infiltration of saline superomedially to the femoral artery via perineural catheter.</description>
    <arm_group_label>Saline Sham Group</arm_group_label>
    <other_name>Salt water placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Perifemoral Injection of Local Anesthetic</intervention_name>
    <description>Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.</description>
    <arm_group_label>Mepivacaine Block Group</arm_group_label>
    <other_name>Femoral Periarterial Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Perifemoral Injection of Local Anesthetic</intervention_name>
    <description>Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.</description>
    <arm_group_label>Saline Sham Group</arm_group_label>
    <other_name>Femoral Periarterial Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients that will be included in the study are English speaking 18-75 year old ASA 1-3&#xD;
        patients undergoing total ankle arthroplasty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ASA 4 or 5&#xD;
&#xD;
          2. Diagnosis of chronic pain&#xD;
&#xD;
          3. Daily chronic opioid use (over 3 months of continuous opioid use).&#xD;
&#xD;
          4. Inability to communicate pain scores or need for analgesia.&#xD;
&#xD;
          5. Infection at the site of block placement&#xD;
&#xD;
          6. Age under 18 years old or greater than 75 years old&#xD;
&#xD;
          7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)&#xD;
&#xD;
          8. Intolerance/allergy to local anesthetics&#xD;
&#xD;
          9. Weight &lt;50 kg&#xD;
&#xD;
         10. Suspected, or known addiction to or abuse of illicit drug(s), prescription&#xD;
             medicine(s), or alcohol within the past 2 years.&#xD;
&#xD;
         11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the&#xD;
             opinion of the investigator, may interfere with study assessments or compliance.&#xD;
&#xD;
         12. Current or historical evidence of any clinically significant disease or condition&#xD;
             that, in the opinion of the investigator, may increase the risk of surgery or&#xD;
             complicate the subject's postoperative course&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Kumar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William M Bullock, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>William M Bullock, MD, PhD</last_name>
    <phone>919-681-6437</phone>
    <email>william.bullock@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeff C Gadsden, MD</last_name>
    <phone>919-681-6437</phone>
    <email>jeff.gadsden@duke.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William M Bullock, MD, PhD</last_name>
      <phone>919-681-6437</phone>
      <email>william.bullock@duke.edu</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Kumar, MD</last_name>
      <phone>919-681-6437</phone>
      <email>amanda.kumar@duke.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Amanda Kumar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>William M Bullock, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeff C Gadsden, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perifemoral</keyword>
  <keyword>Tourniquet</keyword>
  <keyword>Mepivacaine</keyword>
  <keyword>Tourniquet Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.</ipd_description>
  </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/NCT04454203
org study id: Pro00104144
nct id: NCT04454203
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this prospective randomized double-blind study is to determine if an ultrasound
      guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via
      peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower
      extremity tourniquet time.
This is a research study to find out if injection of numbing medication by the large artery
      going down your leg will improve high blood pressure caused by the tourniquet.

      Depending on whether you enroll in this study, you may receive an injection of local
      anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large
      artery going down your leg). This is to see how this injection impacts your blood pressure
      during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help
      decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to
      go up, but the numbing medication may help return your blood pressure close to its normal
      level. The rest of your anesthesia care, including other nerve blocks and general anesthetic,
      will be the same as it would be without participating in the study. You will be enrolled in
      this study for 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Change in tourniquet hypertension as measured by systolic blood pressure
time frame: From time of injection to 30 minutes after injection
description: Infiltrating study drug to reverse intraoperative tourniquet hypertension
measure: Pain Scores (NRS11)
time frame: Perioperative start until 2 hours after admission to PACU
description: The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
measure: Opioid consumption
time frame: Perioperative start until 2 hours after admission to PACU
description: Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
measure: Quadriceps motor function
time frame: 1 hour after extubation
description: Gross quadriceps motor function as measured by leg extension
arm group label: Mepivacaine Block Group
arm group type: Experimental
description: Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
arm group label: Saline Sham Group
arm group type: Placebo Comparator
description: Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
intervention type: Drug
intervention name: Mepivacaine
description: An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
arm group label: Mepivacaine Block Group
other name: Carbocaine
intervention type: Drug
intervention name: Saline
description: An infiltration of saline superomedially to the femoral artery via perineural catheter.
arm group label: Saline Sham Group
other name: Salt water placebo
intervention type: Procedure
intervention name: Perifemoral Injection of Local Anesthetic
description: Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
arm group label: Mepivacaine Block Group
other name: Femoral Periarterial Injection
intervention type: Procedure
intervention name: Perifemoral Injection of Local Anesthetic
description: Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.
arm group label: Saline Sham Group
other name: Femoral Periarterial Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Kumar, MD, PhD
role: Principal Investigator
affiliation: Duke University
last name: William M Bullock, MD, PhD
role: Study Director
affiliation: Duke University
last name: William M Bullock, MD, PhD
phone: 919-681-6437
email: william.bullock@duke.edu
last name: Jeff C Gadsden, MD
phone: 919-681-6437
email: jeff.gadsden@duke.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Anesthetics
mesh term: Mepivacaine
mesh term: Anesthetics, Local
sharing ipd: No
ipd description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.