xml: <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/NCT06028126</url>
    </required_header>
    <id_info>
      <org_study_id>23-038</org_study_id>
      <nct_id>NCT06028126</nct_id>
    </id_info>
    <brief_title>Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial</brief_title>
    <acronym>EPOCH</acronym>
    <official_title>Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Unity Health Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Unity Health Toronto</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess whether the use of intermittent superficial&#xD;
        parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac&#xD;
        surgery with median sternotomy.&#xD;
  &#xD;
        Participants randomized to the intervention group will receive the blocks with 0.2%&#xD;
        ropivacaine administered via catheters placed in the superficial parasternal intercostal&#xD;
        plane bilaterally under ultrasound guidance. Researchers will compare this group with a&#xD;
        control group given 0.9% saline through similarly placed catheters. The primary outcome will&#xD;
        be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up&#xD;
        to 72 hours following catheter insertion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal&#xD;
        intercostal plane block and to measure whether there are any tangible changes in:&#xD;
  &#xD;
          1. cumulative postoperative opioid use from catheter insertion until hospital discharge -&#xD;
             measured as Milligram Morphine Equivalent (MME)&#xD;
  &#xD;
          2. median pain score - measured at rest and with coughing using a standardized numerical&#xD;
             rating scale - over 72 hours post catheter insertion&#xD;
  &#xD;
          3. delirium - assessed twice daily using institutional scores up to 72 hours following&#xD;
             catheter insertion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>N/A</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>
      <masking_description>The patient, intervention appliers (i.e. the operating room staff), medical practitioners, and outcome assessors will all be blinded to the randomized treatment arm until the database is locked. Unblinding procedures will be made available for breaking codes if necessary for clinical treatment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative postoperative opioid use up to 72 hours</measure>
      <time_frame>72 hours</time_frame>
      <description>Postoperative opioid use measured using Milligram Morphine Equivalent</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Median pain score</measure>
      <time_frame>over 72 hours post-extubation</time_frame>
      <description>Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative post-operative opioid use</measure>
      <time_frame>from time of catheter insertion until discharge from hospital</time_frame>
      <description>Measured using Milligram Morphine Equivalent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delirium</measure>
      <time_frame>for 72 hours following catheter insertion</time_frame>
      <description>assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 Scale</measure>
      <time_frame>24-96 hours post surgery</time_frame>
      <description>Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Time from catheter insertion to extubation</measure>
      <time_frame>from time of catheter insertion until extubation</time_frame>
      <description>Measured time from catheter insertion to extubation</description>
    </other_outcome>
    <other_outcome>
      <measure>Time from catheter insertion to first analgesic request</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>Measured time from catheter insertion to first analgesic request</description>
    </other_outcome>
    <other_outcome>
      <measure>Time from catheter insertion to mobilization</measure>
      <time_frame>From the time of catheter insertion to mobilization</time_frame>
      <description>Measured time from catheter insertion to mobilization</description>
    </other_outcome>
    <other_outcome>
      <measure>ICU and hospital length of stay</measure>
      <time_frame>From date of surgery until date of ICU and Hospital discharge</time_frame>
      <description>Measured time of ICU and hospital length of stay</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative nausea and vomiting</measure>
      <time_frame>Up to 72 hours following catheter insertion</time_frame>
      <description>Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse)</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of Recovery-15 Scale</measure>
      <time_frame>Post-operative day 4-7</time_frame>
      <description>Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome)</description>
    </other_outcome>
    <other_outcome>
      <measure>Post thoracotomy Pain</measure>
      <time_frame>Assessed at 3 months +/- 4 weeks</time_frame>
      <description>Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome) and Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS 29) Subsections:&#xD;
  Physical Function: 4-20, higher scores is better outcome. Anxiety: 4-20, higher scores is worse outcome. Depression: 4-20, higher scores is worse outcome. Fatigue: 4-20, higher scores is worse outcome. Sleep Disturbance: 4-20, higher scores is worse outcome. Ability to Participate in Social Roles and Activities: 4-20, higher scores is better outcome.&#xD;
  Pain Interference: 4-20, higher scores is worse outcome. Pain Intensity: 0-10 higher scores is worse outcome.)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">310</enrollment>
    <condition>Post-operative Pain</condition>
    <condition>Post-operative Delirium</condition>
    <condition>Post-cardiac Surgery</condition>
    <condition>Chronic Pain</condition>
    <condition>Opioid Use Disorder</condition>
    <condition>Anesthesia, Local</condition>
    <arm_group>
      <arm_group_label>0.2% ropivacaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side at the time of catheter placement, followed by intermittent boluses of 10 mL 0.2% ropivacaine per side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.9% saline</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Intermitted superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus of 20 mL of 0.9% saline per side at the time of catheter placement, followed by intermitted boluses of 10 ml of 0.9% saline per side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intermittent Superficial Parasternal Intercostal Plane Block - Experimental</intervention_name>
      <description>Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.&#xD;
  Following initial bolus dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.</description>
      <arm_group_label>0.2% ropivacaine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intermittent Superficial Parasternal Intercostal Plane Block - Sham</intervention_name>
      <description>Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.&#xD;
  Following initial bolus dosing at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.</description>
      <arm_group_label>0.9% saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients undergoing cardiac surgery via median sternotomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches&#xD;
               (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)&#xD;
  &#xD;
            -  Emergency procedures (surgery within 2 hours)&#xD;
  &#xD;
            -  Clinical instability which in the judgement of the investigator precludes enrollment&#xD;
               or participation in the study&#xD;
  &#xD;
            -  Weight &lt; 50kg&#xD;
  &#xD;
            -  Active systemic bacterial infection including infective endocarditis or pre-existing&#xD;
               sternal infections&#xD;
  &#xD;
            -  Surgery for infective endocarditis&#xD;
  &#xD;
            -  Pregnancy or nursing&#xD;
  &#xD;
            -  Chronic opioid/narcotic use &gt; 6 weeks, active use of illicit drugs, long-term opioid&#xD;
               exposure or chronic pain disorder/syndromes&#xD;
  &#xD;
            -  Allergies to amide anesthetic agents or any components of study interventions&#xD;
  &#xD;
            -  Inability to comply with, or participate in, protocol (i.e. cognitive&#xD;
               impairment/altered mental status/neurological deficit or disorder, inability to&#xD;
               provide informed consent, inability to complete pain rating scales, etc.)&#xD;
  &#xD;
            -  Receipt of an investigational drug or device within past 7 days&#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>Ahmad Alli, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Unity Health Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Adrian Quan, M.Phil.</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>77626</phone_ext>
      <email>adrian.quan@unityhealth.to</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmad Alli, MD</last_name>
      <phone>4373441546</phone>
      <email>ahmad.alli@unityhealth.to</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>St. Michael's Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5B 1W8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmad Alli</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.</citation>
      <PMID>10936130</PMID>
    </reference>
    <reference>
      <citation>Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.</citation>
      <PMID>31054241</PMID>
    </reference>
    <reference>
      <citation>Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291.</citation>
      <PMID>34601602</PMID>
    </reference>
    <reference>
      <citation>Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.</citation>
      <PMID>36581838</PMID>
    </reference>
    <reference>
      <citation>Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.</citation>
      <PMID>32859487</PMID>
    </reference>
    <reference>
      <citation>Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.</citation>
      <PMID>32584934</PMID>
    </reference>
    <reference>
      <citation>Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.</citation>
      <PMID>22956490</PMID>
    </reference>
    <reference>
      <citation>Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55.</citation>
      <PMID>6150663</PMID>
    </reference>
    <reference>
      <citation>Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.</citation>
      <PMID>29026331</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
      <investigator_full_name>Ahmad Alli</investigator_full_name>
      <investigator_title>Director of CVICU</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergence Delirium</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028126
  org study id: 23-038
  nct id: NCT06028126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess whether the use of intermittent superficial
        parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac
        surgery with median sternotomy.
  
        Participants randomized to the intervention group will receive the blocks with 0.2%
        ropivacaine administered via catheters placed in the superficial parasternal intercostal
        plane bilaterally under ultrasound guidance. Researchers will compare this group with a
        control group given 0.9% saline through similarly placed catheters. The primary outcome will
        be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up
        to 72 hours following catheter insertion.
  This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal
        intercostal plane block and to measure whether there are any tangible changes in:
  
          1. cumulative postoperative opioid use from catheter insertion until hospital discharge -
             measured as Milligram Morphine Equivalent (MME)
  
          2. median pain score - measured at rest and with coughing using a standardized numerical
             rating scale - over 72 hours post catheter insertion
  
          3. delirium - assessed twice daily using institutional scores up to 72 hours following
             catheter insertion.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The patient, intervention appliers (i.e. the operating room staff), medical practitioners, and outcome assessors will all be blinded to the randomized treatment arm until the database is locked. Unblinding procedures will be made available for breaking codes if necessary for clinical treatment.
  measure: Cumulative postoperative opioid use up to 72 hours
  time frame: 72 hours
  description: Postoperative opioid use measured using Milligram Morphine Equivalent
  measure: Median pain score
  time frame: over 72 hours post-extubation
  description: Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)
  measure: Cumulative post-operative opioid use
  time frame: from time of catheter insertion until discharge from hospital
  description: Measured using Milligram Morphine Equivalent
  measure: Delirium
  time frame: for 72 hours following catheter insertion
  description: assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist.
  measure: Quality of Recovery-15 Scale
  time frame: 24-96 hours post surgery
  description: Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)
  measure: Time from catheter insertion to extubation
  time frame: from time of catheter insertion until extubation
  description: Measured time from catheter insertion to extubation
  measure: Time from catheter insertion to first analgesic request
  time frame: immediately after the intervention
  description: Measured time from catheter insertion to first analgesic request
  measure: Time from catheter insertion to mobilization
  time frame: From the time of catheter insertion to mobilization
  description: Measured time from catheter insertion to mobilization
  measure: ICU and hospital length of stay
  time frame: From date of surgery until date of ICU and Hospital discharge
  description: Measured time of ICU and hospital length of stay
  measure: Postoperative nausea and vomiting
  time frame: Up to 72 hours following catheter insertion
  description: Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse)
  measure: Quality of Recovery-15 Scale
  time frame: Post-operative day 4-7
  description: Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome)
  measure: Post thoracotomy Pain
  time frame: Assessed at 3 months +/- 4 weeks
  description: Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome) and Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS 29) Subsections:
  Physical Function: 4-20, higher scores is better outcome. Anxiety: 4-20, higher scores is worse outcome. Depression: 4-20, higher scores is worse outcome. Fatigue: 4-20, higher scores is worse outcome. Sleep Disturbance: 4-20, higher scores is worse outcome. Ability to Participate in Social Roles and Activities: 4-20, higher scores is better outcome.
  Pain Interference: 4-20, higher scores is worse outcome. Pain Intensity: 0-10 higher scores is worse outcome.)
  arm group label: 0.2% ropivacaine
  arm group type: Experimental
  description: Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side at the time of catheter placement, followed by intermittent boluses of 10 mL 0.2% ropivacaine per side.
  arm group label: 0.9% saline
  arm group type: Sham Comparator
  description: Intermitted superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus of 20 mL of 0.9% saline per side at the time of catheter placement, followed by intermitted boluses of 10 ml of 0.9% saline per side.
  intervention type: Procedure
  intervention name: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental
  description: Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.
  Following initial bolus dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
  arm group label: 0.2% ropivacaine
  intervention type: Procedure
  intervention name: Intermittent Superficial Parasternal Intercostal Plane Block - Sham
  description: Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.
  Following initial bolus dosing at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
  arm group label: 0.9% saline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ahmad Alli, MD
  role: Principal Investigator
  affiliation: Unity Health Toronto
  last name: Adrian Quan, M.Phil.
  phone: 416-864-6060
  phone ext: 77626
  email: adrian.quan@unityhealth.to
  last name: Ahmad Alli, MD
  phone: 4373441546
  email: ahmad.alli@unityhealth.to
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  citation: Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
  PMID: 10936130
  citation: Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
  PMID: 31054241
  citation: Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291.
  PMID: 34601602
  citation: Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.
  PMID: 36581838
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  responsible party type: Principal Investigator
  investigator affiliation: Unity Health Toronto
  investigator full name: Ahmad Alli
  investigator title: Director of CVICU
  mesh term: Emergence Delirium
  mesh term: Chronic Pain
  mesh term: Pain, Postoperative
  mesh term: Opioid-Related Disorders
  sharing ipd: No