<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/NCT02980835</url>
  </required_header>
  <id_info>
    <org_study_id>721921</org_study_id>
    <nct_id>NCT02980835</nct_id>
  </id_info>
  <brief_title>Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries</brief_title>
  <official_title>Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The VA Western New York Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University at Buffalo</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intercostal nerve block, performed under the guidance of videoscope, is a part of standard&#xD;
      anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this&#xD;
      double-blind, prospective, multi-center, randomized, controlled clinical trial the&#xD;
      investigators aim to compare preemptive versus post-closure intercostal injection of&#xD;
      ropivacaine in controlling post-video-assisted thoracotomy pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design of the study is a double-blind, prospective, multi-center, randomized, controlled&#xD;
      clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in&#xD;
      controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block&#xD;
      procedures, the contents of A (a total of a 10 mL-solution that consists of 9 mL of&#xD;
      ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and C (a total 25 mL&#xD;
      solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL&#xD;
      preparation, and 0.125 mL of epinephrine-1:1000 preparation) are combined into one set of&#xD;
      injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with&#xD;
      each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal&#xD;
      space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is&#xD;
      split into two sets of injections: one set of injections at the beginning of VATS, and the&#xD;
      other set right before closure. Therefore the investigators consider both sets of injections&#xD;
      as research procedures. Patients will be randomly assigned to receive a preemptive&#xD;
      2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each&#xD;
      intercostal space as previously delineated by the operating surgeon. Both the research team&#xD;
      and the surgical team will be blind to the nature of the injectates during surgery. As parts&#xD;
      of the standard care procedures, all patients will be monitored with non-invasive ASA&#xD;
      standard in addition to invasive arterial blood pressure monitoring. Prior to the closure,&#xD;
      patients who receive injections of A at the beginning of surgery will receive the second set&#xD;
      of injections containing a mixture of B and C (5 mL of solution C is given at each&#xD;
      intercostal space) at the intercostal spaces as previously delineated. Patients who receive&#xD;
      injections of B at the beginning of surgery will receive the second set of injections&#xD;
      containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The&#xD;
      investigators will group the patients who are assigned to receive injectate A at the end of&#xD;
      the surgery as the control group. Because the injectate A and injectate C are usually given&#xD;
      together in one set of injections at the same anatomical locations in standard intercostal&#xD;
      nerve block procedures, the intercostal block received by the control group will closely&#xD;
      resemble the procedures performed in standard intercostal nerve block. Patients who receive&#xD;
      injectate A at the beginning of surgery are grouped as experimental group. Regardless of the&#xD;
      group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will&#xD;
      be equal to the dosage given under the standard care procedures. Post operative pain,&#xD;
      ventilatory profile and length of hospital stay will be compared between two study arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2016</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</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>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>0</time_frame>
    <description>VAS scores at rest will be recorded right after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>6 hours</time_frame>
    <description>VAS scores at rest will be recorded 6 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>12 hours</time_frame>
    <description>VAS scores at rest will be recorded 12 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>18 hours</time_frame>
    <description>VAS scores at rest will be recorded 18 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>24 hours</time_frame>
    <description>VAS scores at rest will be recorded 24 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>48 hours</time_frame>
    <description>VAS scores at rest will be recorded 48 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score</measure>
    <time_frame>72 hours</time_frame>
    <description>VAS scores at rest will be recorded 72 hours after surgery and compared in both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)</measure>
    <time_frame>12 hours</time_frame>
    <description>Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)</measure>
    <time_frame>36 hours</time_frame>
    <description>Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)</measure>
    <time_frame>48 hours</time_frame>
    <description>Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2/FIO2 ratio right after surgery</measure>
    <time_frame>0 hours</time_frame>
    <description>PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital length of stay</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for non-invasive positive pressure ventilation (NIPPV)</measure>
    <time_frame>up to two weeks</time_frame>
    <description>The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for mechanical ventilation</measure>
    <time_frame>up to two weeks</time_frame>
    <description>The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Video-Assisted Thoracic Surgery</condition>
  <condition>Video-Assisted Thoracoscopic Surgery</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine</intervention_name>
    <description>Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be eligible to enroll in this study if they:&#xD;
&#xD;
          -  Have physical status within ASA class II or III&#xD;
&#xD;
          -  Are between 18 and 85 years of age&#xD;
&#xD;
          -  Are candidates for VATS&#xD;
&#xD;
          -  Are able to complete VAS assessments&#xD;
&#xD;
          -  Are competent to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will not be enrolled in this study if they:&#xD;
&#xD;
          -  Are pregnant&#xD;
&#xD;
          -  Have allergy to ropivacaine or hydromorphone&#xD;
&#xD;
          -  Have renal insufficiency (eGFR&lt;60mL/min/1.73m2)&#xD;
&#xD;
          -  Have hepatic insufficiency (AST, ALT, or both &gt;60 U/L) or cirrhosis&#xD;
&#xD;
          -  Have a predicted postoperative forced vital capacity (FVC) of &lt;40%, predicted forced&#xD;
             expiratory volume at 1s (FEV1) &lt;40%&#xD;
&#xD;
          -  Have coagulopathy (platelet count&lt;50000, INR&gt;2, or both)&#xD;
&#xD;
          -  Have a history of opioid addiction, chronically taking opioids, currently taking high&#xD;
             dose of opioids or currently taking opioid agonist+antagonist (e.g. Suboxone®)&#xD;
&#xD;
          -  Are taking nonsteroidal anti-inflammatory drug, including aspirin, within a week prior&#xD;
             to surgery (since the analgesic effects of NSAID drugs may become confounding&#xD;
             factors).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Western New York Healthcare System</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Buffalo</investigator_affiliation>
    <investigator_full_name>Nader D Nader</investigator_full_name>
    <investigator_title>Professor and Senior Vice Chair</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators don't plan to make individual participant data (IPD) available to other researchers.</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/NCT02980835
org study id: 721921
nct id: NCT02980835
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard
      anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this
      double-blind, prospective, multi-center, randomized, controlled clinical trial the
      investigators aim to compare preemptive versus post-closure intercostal injection of
      ropivacaine in controlling post-video-assisted thoracotomy pain.
The design of the study is a double-blind, prospective, multi-center, randomized, controlled
      clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in
      controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block
      procedures, the contents of A (a total of a 10 mL-solution that consists of 9 mL of
      ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and C (a total 25 mL
      solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL
      preparation, and 0.125 mL of epinephrine-1:1000 preparation) are combined into one set of
      injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with
      each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal
      space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is
      split into two sets of injections: one set of injections at the beginning of VATS, and the
      other set right before closure. Therefore the investigators consider both sets of injections
      as research procedures. Patients will be randomly assigned to receive a preemptive
      2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each
      intercostal space as previously delineated by the operating surgeon. Both the research team
      and the surgical team will be blind to the nature of the injectates during surgery. As parts
      of the standard care procedures, all patients will be monitored with non-invasive ASA
      standard in addition to invasive arterial blood pressure monitoring. Prior to the closure,
      patients who receive injections of A at the beginning of surgery will receive the second set
      of injections containing a mixture of B and C (5 mL of solution C is given at each
      intercostal space) at the intercostal spaces as previously delineated. Patients who receive
      injections of B at the beginning of surgery will receive the second set of injections
      containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The
      investigators will group the patients who are assigned to receive injectate A at the end of
      the surgery as the control group. Because the injectate A and injectate C are usually given
      together in one set of injections at the same anatomical locations in standard intercostal
      nerve block procedures, the intercostal block received by the control group will closely
      resemble the procedures performed in standard intercostal nerve block. Patients who receive
      injectate A at the beginning of surgery are grouped as experimental group. Regardless of the
      group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will
      be equal to the dosage given under the standard care procedures. Post operative pain,
      ventilatory profile and length of hospital stay will be compared between two study arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 0
description: VAS scores at rest will be recorded right after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 6 hours
description: VAS scores at rest will be recorded 6 hours after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 12 hours
description: VAS scores at rest will be recorded 12 hours after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 18 hours
description: VAS scores at rest will be recorded 18 hours after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 24 hours
description: VAS scores at rest will be recorded 24 hours after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 48 hours
description: VAS scores at rest will be recorded 48 hours after surgery and compared in both groups
measure: Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
time frame: 72 hours
description: VAS scores at rest will be recorded 72 hours after surgery and compared in both groups
measure: Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
time frame: 12 hours
description: Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
measure: Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
time frame: 24 hours
description: Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
measure: Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
time frame: 36 hours
description: Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
measure: Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
time frame: 48 hours
description: Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
measure: PaO2/FIO2 ratio right after surgery
time frame: 0 hours
description: PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated
measure: Total hospital length of stay
time frame: up to 2 weeks
description: The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission
measure: Need for non-invasive positive pressure ventilation (NIPPV)
time frame: up to two weeks
description: The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization
measure: Need for mechanical ventilation
time frame: up to two weeks
description: The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization
arm group label: Intervention
arm group type: Experimental
description: Patients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure
arm group label: Control
arm group type: Active Comparator
description: Participants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group
intervention type: Drug
intervention name: Normal Saline
description: Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.
arm group label: Control
arm group label: Intervention
intervention type: Drug
intervention name: Ropivacaine
description: Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.
arm group label: Control
arm group label: Intervention
intervention type: Drug
intervention name: Epinephrine
description: Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.
arm group label: Control
arm group label: Intervention
intervention type: Drug
intervention name: Dexamethasone
description: Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University at Buffalo
investigator full name: Nader D Nader
investigator title: Professor and Senior Vice Chair
mesh term: Aortic Dissection
mesh term: Dexamethasone
mesh term: Epinephrine
mesh term: Ropivacaine
sharing ipd: No
ipd description: The investigators don't plan to make individual participant data (IPD) available to other researchers.