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/NCT05999721</url>
    </required_header>
    <id_info>
      <org_study_id>0577-23-RMC</org_study_id>
      <nct_id>NCT05999721</nct_id>
    </id_info>
    <brief_title>The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery</brief_title>
    <acronym>PIPACS</acronym>
    <official_title>The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shai Fein</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rabin Medical Center</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>
        In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care&#xD;
        compared to standard care alone result in a smaller decrease in PFTs?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative pulmonary complications pose a significant concern after cardiac surgery.&#xD;
        Post-sternotomy pain plays a key role in impaired pulmonary function tests, ultimately&#xD;
        increasing the risk of postoperative pulmonary complications. Parasternal intercostal plane&#xD;
        blocks have recently emerged as a promising analgesic modality for cardiac surgery. However,&#xD;
        the impact of parasternal intercostal plane blocks on pulmonary function tests remains&#xD;
        unexplored.&#xD;
  &#xD;
        In this prospective, single-centre, double-blind, randomised controlled trial, a total of 100&#xD;
        participants undergoing elective cardiac surgery will be recruited. Prior to surgery,&#xD;
        baseline pulmonary function tests will be measured. Throughout the surgical procedure, all&#xD;
        participants will receive identical anaesthesia and surgical protocols. At the end of the&#xD;
        surgery and after sternal wound closure, participants will be randomly assigned to one of two&#xD;
        research arms in a 1:1 ratio. The treatment arm will receive a superficial parasternal&#xD;
        intercostal plane block in addition to standard care, while the control arm will receive&#xD;
        standard care alone. Pulmonary function tests, pain scores, and opioid consumption will be&#xD;
        recorded daily until the third postoperative day. The primary outcome is the difference&#xD;
        between pre and postoperative PFTs values. Secondary outcomes are pain scores, opioid&#xD;
        consumption, the incidence of postoperative pulmonary complications during current&#xD;
        hospitalisation, cardiothoracic intensive care unit, hospital length stay, and 30-day&#xD;
        mortality.&#xD;
  &#xD;
        Pulmonary function tests were selected as the primary outcome due to their practicality and&#xD;
        relevance to the postoperative course. The superficial parasternal intercostal plane block&#xD;
        was chosen as the study intervention due to its simplicity and feasibility. The hypothesis&#xD;
        posits that the addition of this intervention to standard care compared to standard care&#xD;
        alone results in a smaller decrease in pulmonary function tests.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak expiratory flow rates (PEFR), measured in liters per second</measure>
      <time_frame>72 hours</time_frame>
      <description>The difference between daily PEFR measurements until the third postoperative day compared to baseline values</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced expiratory volume in the first second (FEV1), measured in liters</measure>
      <time_frame>72 hours</time_frame>
      <description>The difference between daily FEV1 measurements until the third postoperative day compared to baseline values</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced vital capacity (FVC), measured in liters</measure>
      <time_frame>72 hours</time_frame>
      <description>The difference between daily FVC measurements until the third postoperative day compared to baseline values</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain scores, measured by visual numeric scale (VNS)</measure>
      <time_frame>72 hours</time_frame>
      <description>Daily VNS scores measurment until the third postoperative day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid consumption, measured in morphine milligram equivalence (MME)</measure>
      <time_frame>72 hours</time_frame>
      <description>Daily MME measurment until the third postoperative day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria</measure>
      <time_frame>30 days</time_frame>
      <description>The incidence of postoperative pulmonary complications during current hospitalisation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>30 days</time_frame>
      <description>The length of cardiothoracic intensive care unit and hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>30 days</time_frame>
      <description>Thirty-day mortality</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Pulmonary Function Tests</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control arm will receive standard care alone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>superficial parasternal intercostal plane block</intervention_name>
      <description>Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard care</intervention_name>
      <description>Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg -1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Moreover, patients will receive intravenous multimodal analgesics, including paracetamol 1 g, tramadol 100 mg, and dipyrone 1 g.&#xD;
  In the cardiothoracic intensive care unit, anaesthesia will be maintained using continuous fentanyl (2-5 μg kg-1) until tracheal extubation. After tracheal extubation, patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1, tramadol 300 mg day-1, and dipyrone 3 g day-1. If the patients are still in pain, rescue doses of intravenous morphine 5 mg will be administered.</description>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e.,&#xD;
               coronary artery bypass graft, valve replacement, valve repair).&#xD;
  &#xD;
            -  Body Mass Index (BMI) above 20 and below 40 kg m-2.&#xD;
  &#xD;
            -  Age above 18 years.&#xD;
  &#xD;
            -  Eligible to sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Redo surgery.&#xD;
  &#xD;
            -  Off-pump surgeries.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump,&#xD;
               extracorporeal membrane oxygenation, ventricular assist devices).&#xD;
  &#xD;
            -  Preoperative chronic pain (i.e., fibromyalgia, post-sternotomy pain syndrome, chronic&#xD;
               neuropathic pain).&#xD;
  &#xD;
            -  Contraindication for regional analgesia (i.e., known allergy to local anaesthetics,&#xD;
               skin lesions in the injection site).&#xD;
  &#xD;
            -  Known allergy to one or more of the components of multimodal analgesia (i.e., opioids,&#xD;
               paracetamol, tramadol, dipyrone).&#xD;
  &#xD;
            -  Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1&#xD;
               below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension).&#xD;
  &#xD;
          Criteria For Discontinuing (Postoperative Exclusion Criteria):&#xD;
  &#xD;
            -  Prolonged cardiopulmonary bypass (CPB) of more than three hours.&#xD;
  &#xD;
            -  Transfusion of more than three units of blood products.&#xD;
  &#xD;
            -  Severe coagulation disturbance requiring prothrombin complex concentrate or&#xD;
               recombinant factor VII.&#xD;
  &#xD;
            -  Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the&#xD;
               surgery of ≥ 20.&#xD;
  &#xD;
            -  Right ventricular failure requires inhaled nitric oxide.&#xD;
  &#xD;
            -  Need for mechanical circulatory support (i.e., intra-aortic balloon pump,&#xD;
               extracorporeal membrane oxygenation).&#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>Shai Fein, MD, MHA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rabin Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shai Fein, MD, MHA</last_name>
      <phone>+972 52 8989630</phone>
      <email>shaifein812@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karam Azem, MD</last_name>
      <phone>+972 50 4705001</phone>
      <email>dr.azem.k@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rabin Medical Center</name>
        <address>
          <city>Petach Tikva</city>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Shai Fein, MD, MHA</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
      <investigator_full_name>Shai Fein</investigator_full_name>
      <investigator_title>Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.</investigator_title>
    </responsible_party>
    <keyword>Superficial Parasternal Intercostal Plane Block</keyword>
    <keyword>Pulmonary function tests</keyword>
    <keyword>Cardiac surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Participant-level datasets and statistical code will be provided upon request.</ipd_description>
    </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/NCT05999721
  org study id: 0577-23-RMC
  nct id: NCT05999721
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care
        compared to standard care alone result in a smaller decrease in PFTs?
  Postoperative pulmonary complications pose a significant concern after cardiac surgery.
        Post-sternotomy pain plays a key role in impaired pulmonary function tests, ultimately
        increasing the risk of postoperative pulmonary complications. Parasternal intercostal plane
        blocks have recently emerged as a promising analgesic modality for cardiac surgery. However,
        the impact of parasternal intercostal plane blocks on pulmonary function tests remains
        unexplored.
  
        In this prospective, single-centre, double-blind, randomised controlled trial, a total of 100
        participants undergoing elective cardiac surgery will be recruited. Prior to surgery,
        baseline pulmonary function tests will be measured. Throughout the surgical procedure, all
        participants will receive identical anaesthesia and surgical protocols. At the end of the
        surgery and after sternal wound closure, participants will be randomly assigned to one of two
        research arms in a 1:1 ratio. The treatment arm will receive a superficial parasternal
        intercostal plane block in addition to standard care, while the control arm will receive
        standard care alone. Pulmonary function tests, pain scores, and opioid consumption will be
        recorded daily until the third postoperative day. The primary outcome is the difference
        between pre and postoperative PFTs values. Secondary outcomes are pain scores, opioid
        consumption, the incidence of postoperative pulmonary complications during current
        hospitalisation, cardiothoracic intensive care unit, hospital length stay, and 30-day
        mortality.
  
        Pulmonary function tests were selected as the primary outcome due to their practicality and
        relevance to the postoperative course. The superficial parasternal intercostal plane block
        was chosen as the study intervention due to its simplicity and feasibility. The hypothesis
        posits that the addition of this intervention to standard care compared to standard care
        alone results in a smaller decrease in pulmonary function tests.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Peak expiratory flow rates (PEFR), measured in liters per second
  time frame: 72 hours
  description: The difference between daily PEFR measurements until the third postoperative day compared to baseline values
  measure: Forced expiratory volume in the first second (FEV1), measured in liters
  time frame: 72 hours
  description: The difference between daily FEV1 measurements until the third postoperative day compared to baseline values
  measure: Forced vital capacity (FVC), measured in liters
  time frame: 72 hours
  description: The difference between daily FVC measurements until the third postoperative day compared to baseline values
  measure: Pain scores, measured by visual numeric scale (VNS)
  time frame: 72 hours
  description: Daily VNS scores measurment until the third postoperative day
  measure: Opioid consumption, measured in morphine milligram equivalence (MME)
  time frame: 72 hours
  description: Daily MME measurment until the third postoperative day
  measure: Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria
  time frame: 30 days
  description: The incidence of postoperative pulmonary complications during current hospitalisation
  measure: Length of stay
  time frame: 30 days
  description: The length of cardiothoracic intensive care unit and hospital stay
  measure: Mortality
  time frame: 30 days
  description: Thirty-day mortality
  arm group label: Treatment Arm
  arm group type: Active Comparator
  description: In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels.
  arm group label: Control Arm
  arm group type: Active Comparator
  description: The control arm will receive standard care alone.
  intervention type: Procedure
  intervention name: superficial parasternal intercostal plane block
  description: Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
  arm group label: Treatment Arm
  intervention type: Other
  intervention name: Standard care
  description: Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg -1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Moreover, patients will receive intravenous multimodal analgesics, including paracetamol 1 g, tramadol 100 mg, and dipyrone 1 g.
  In the cardiothoracic intensive care unit, anaesthesia will be maintained using continuous fentanyl (2-5 μg kg-1) until tracheal extubation. After tracheal extubation, patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1, tramadol 300 mg day-1, and dipyrone 3 g day-1. If the patients are still in pain, rescue doses of intravenous morphine 5 mg will be administered.
  arm group label: Control Arm
  arm group label: Treatment Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shai Fein, MD, MHA
  role: Principal Investigator
  affiliation: Rabin Medical Center
  last name: Shai Fein, MD, MHA
  phone: +972 52 8989630
  email: shaifein812@gmail.com
  last name: Karam Azem, MD
  phone: +972 50 4705001
  email: dr.azem.k@gmail.com
  facility: 
  contact: 
  country: Israel
  responsible party type: Sponsor-Investigator
  investigator affiliation: Rabin Medical Center
  investigator full name: Shai Fein
  investigator title: Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.
  mesh term: Pain, Postoperative
  sharing ipd: No
  ipd description: Participant-level datasets and statistical code will be provided upon request.