<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/NCT04445337</url>
  </required_header>
  <id_info>
    <org_study_id>603.20.FB</org_study_id>
    <nct_id>NCT04445337</nct_id>
  </id_info>
  <brief_title>Stellate Ganglion Blockade in COVID-19 Positive Patients</brief_title>
  <official_title>Stellate Ganglion Blockade in COVID-19 Positive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will establish the safety and efficacy of using stellate ganglion blocks in&#xD;
      patients with ARDS due to COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient&#xD;
      monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative&#xD;
      equipment will be immediately available. A norepinephrine solution will be at bedside to&#xD;
      treat potential hypotension associated with SGB. The SGB perineural catheter will be placed&#xD;
      using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg,&#xD;
      Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2%&#xD;
      bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue&#xD;
      infusion and remove the catheter after 5 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label use of stellate ganglion block.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS</measure>
    <time_frame>3 month</time_frame>
    <description>Adverse events related to SGB.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS</measure>
    <time_frame>3 month</time_frame>
    <description>All adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>COVID 19</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Open Label SGB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stellate Ganglion Block</intervention_name>
    <description>An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.</description>
    <arm_group_label>Open Label SGB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient between the ages of 19-85 with laboratory established COVID-19 infection&#xD;
             (via rRT-PCR) requiring critical care in an intensive care unit.&#xD;
&#xD;
          -  Signs or symptoms consistent with ARDS must be present.&#xD;
&#xD;
          -  The syndrome must present acutely, PaO2/FIO2 ≤ 200 mm Hg, bilateral infiltrates on&#xD;
             chest radiograph or CT not due to cardiac failure, need for non-invasive or invasive&#xD;
             mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamic instability (&gt;2 vasopressors)&#xD;
&#xD;
          -  pre-hospital diagnosis of heart failure or fluid overload&#xD;
&#xD;
          -  anatomical inability to perform block&#xD;
&#xD;
          -  prior sympathectomy&#xD;
&#xD;
          -  patient currently enrolled in another clinical trial for COVID-19 or respiratory&#xD;
             distress/ARDS&#xD;
&#xD;
          -  uncorrectable coagulopathy, already on ECMO, already on Nitric Oxide, pre-existing&#xD;
             multi-organ failure (&gt;2 organ systems).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Michael Lankhorst</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>stellate ganglion</keyword>
  <keyword>perineural block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Ganglion Cysts</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04445337
org study id: 603.20.FB
nct id: NCT04445337
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will establish the safety and efficacy of using stellate ganglion blocks in
      patients with ARDS due to COVID-19 disease.
The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient
      monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative
      equipment will be immediately available. A norepinephrine solution will be at bedside to
      treat potential hypotension associated with SGB. The SGB perineural catheter will be placed
      using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg,
      Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2%
      bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue
      infusion and remove the catheter after 5 days.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label use of stellate ganglion block.
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS
time frame: 3 month
description: Adverse events related to SGB.
measure: Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS
time frame: 3 month
description: All adverse events.
arm group label: Open Label SGB
arm group type: Experimental
description: Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
intervention type: Procedure
intervention name: Stellate Ganglion Block
description: An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
arm group label: Open Label SGB
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Michael Lankhorst
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Ganglion Cysts
sharing ipd: No
submitted: July 14, 2023