<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/NCT04472299</url>
  </required_header>
  <id_info>
    <org_study_id>ANES-2020-28859</org_study_id>
    <nct_id>NCT04472299</nct_id>
  </id_info>
  <brief_title>Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery</brief_title>
  <official_title>Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose if this pilot study is to determine if a perioperative infusion of 0.2%&#xD;
      ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset&#xD;
      atrial fibrillation following primary CABG and/or valve surgery and compare a number of&#xD;
      secondary outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral&#xD;
      catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5%&#xD;
      lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be&#xD;
      administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter&#xD;
      during and after surgery. Patients in the control group will receive no block and undergo&#xD;
      surgery with routine anesthetic care guided by their cardiac anesthesiologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 9, 2021</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of New-Onset Atrial Fibrillation (NOAF)</measure>
    <time_frame>5 days</time_frame>
    <description>The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative Opioid Use - Average Dosages</measure>
    <time_frame>24, 48, 72, 96, and 120 hours post-operatively</time_frame>
    <description>Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Opioid Use - Morphine Equivalents</measure>
    <time_frame>24, 48, 72, 96, and 120 hours post-operatively</time_frame>
    <description>Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Extubation</measure>
    <time_frame>approximately 5 days</time_frame>
    <description>Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit (ICU) Length of Stay</measure>
    <time_frame>approximately 5 days</time_frame>
    <description>Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>approximately 7 days</time_frame>
    <description>Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-Day Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative ICU sedation doses</measure>
    <time_frame>24 and 72 hours post-operatively</time_frame>
    <description>Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of delirium during index hospitalization</measure>
    <time_frame>approximately 7 days</time_frame>
    <description>Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Recovery 15 (QOR-15) Scores</measure>
    <time_frame>24, 48, 72, 96, and 120 hours post-operatively</time_frame>
    <description>The Quality of Recovery 15 is a 15-item survey evaluating recovery after surgery and anaesthesia. Items are rated on a scale 0-10. Total scores are a sum of item scores and range 0-150, with higher scores representing a higher quality of recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain score</measure>
    <time_frame>24, 48, 72, 96, and 120 hours post-operatively</time_frame>
    <description>Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block-associated complications</measure>
    <time_frame>approximately 5 days</time_frame>
    <description>Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block performance time</measure>
    <time_frame>approximately 1 hour</time_frame>
    <description>Outcome reported as the length of time (in minutes) for placement of catheters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of vasopressor requirement</measure>
    <time_frame>approximately 24 hours</time_frame>
    <description>Outcome reported as the length of time (in hours) that participants require vasopressor therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>New Onset Atrial Fibrillation</condition>
  <condition>Anesthesia, Local</condition>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine 0.2% Injectable Solution</intervention_name>
    <description>Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Participants must be undergoing one of the following elective or urgent (but not&#xD;
        emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical&#xD;
        Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D)&#xD;
        Combined CABG &amp; surgical valve replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of atrial fibrillation or flutter&#xD;
&#xD;
          -  Infective endocarditis&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 30%&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Redo surgery&#xD;
&#xD;
          -  Contraindication to block placement including local anesthetic allergy, bleeding&#xD;
             diathesis (physiologic or iatrogenic)&#xD;
&#xD;
          -  Body mass index &gt; 35kg/m2&#xD;
&#xD;
          -  Pregnancy&#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_official>
    <last_name>James Flaherty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Candace Nelson</last_name>
    <phone>612-626-2465</phone>
    <email>nelso377@umn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonah Pearson, MD</last_name>
      <phone>218-280-8348</phone>
      <email>jonahmpearson@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT04472299
org study id: ANES-2020-28859
nct id: NCT04472299
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose if this pilot study is to determine if a perioperative infusion of 0.2%
      ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset
      atrial fibrillation following primary CABG and/or valve surgery and compare a number of
      secondary outcomes.
Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral
      catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5%
      lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be
      administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter
      during and after surgery. Patients in the control group will receive no block and undergo
      surgery with routine anesthetic care guided by their cardiac anesthesiologist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of New-Onset Atrial Fibrillation (NOAF)
time frame: 5 days
description: The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.
measure: Cumulative Opioid Use - Average Dosages
time frame: 24, 48, 72, 96, and 120 hours post-operatively
description: Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.
measure: Cumulative Opioid Use - Morphine Equivalents
time frame: 24, 48, 72, 96, and 120 hours post-operatively
description: Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.
measure: Time to Extubation
time frame: approximately 5 days
description: Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.
measure: Intensive Care Unit (ICU) Length of Stay
time frame: approximately 5 days
description: Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.
measure: Hospital Length of Stay
time frame: approximately 7 days
description: Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.
measure: 30-Day Mortality
time frame: 30 days
description: Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.
measure: Cumulative ICU sedation doses
time frame: 24 and 72 hours post-operatively
description: Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.
measure: Diagnosis of delirium during index hospitalization
time frame: approximately 7 days
description: Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.
measure: Quality of Recovery 15 (QOR-15) Scores
time frame: 24, 48, 72, 96, and 120 hours post-operatively
description: The Quality of Recovery 15 is a 15-item survey evaluating recovery after surgery and anaesthesia. Items are rated on a scale 0-10. Total scores are a sum of item scores and range 0-150, with higher scores representing a higher quality of recovery.
measure: Average pain score
time frame: 24, 48, 72, 96, and 120 hours post-operatively
description: Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).
measure: Block-associated complications
time frame: approximately 5 days
description: Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.
measure: Block performance time
time frame: approximately 1 hour
description: Outcome reported as the length of time (in minutes) for placement of catheters.
measure: Duration of vasopressor requirement
time frame: approximately 24 hours
description: Outcome reported as the length of time (in hours) that participants require vasopressor therapy.
arm group label: Experimental
arm group type: Experimental
description: Participants in this group will receive the intervention.
arm group label: Control
arm group type: No Intervention
description: Participants in this group will receive no intervention.
intervention type: Drug
intervention name: Ropivacaine 0.2% Injectable Solution
description: Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Flaherty, MD
role: Principal Investigator
affiliation: University of Minnesota
last name: Candace Nelson
phone: 612-626-2465
email: nelso377@umn.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Heart Diseases
mesh term: Ropivacaine
sharing ipd: No