<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/NCT04506762</url>
  </required_header>
  <id_info>
    <org_study_id>ESP ERCS</org_study_id>
    <nct_id>NCT04506762</nct_id>
  </id_info>
  <brief_title>Benefit of Peri-operative Bilateral ESP Catheters for Enhanced Recovery for Cardiac Surgery (ERCS)</brief_title>
  <acronym>ESP_ERCS</acronym>
  <official_title>Does Bilateral Continuous Peri Operative Erector Spinae Plane Block Improve The Enhanced Recovery Program After Open Heart Surgeries in Adults?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vinmec Healthcare System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vinmec Healthcare System</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP&#xD;
      catheters improves the enhanced recovery program after open heart surgeries for the duration&#xD;
      of hospitalisation, quality of analgesia, Consumption of peri-operative opioids, quality of&#xD;
      recovery and quality of life.&#xD;
&#xD;
      Patients will be randomly divided in 2 groups Group 1 With the actual standards of care for&#xD;
      enhanced recovery after cardiac surgery including opioid sparing peri operative analgesia&#xD;
      Group 2 With the actual standards of care for enhanced recovery after cardiac surgery&#xD;
      replacing the opioid analgesia by a peri operative analgesia by bilateral ESP catheters&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      I. CONSULTING PHASE: 1 WEEK BEFORE SURGERY&#xD;
&#xD;
        1. Preoperative information, education and counselling: patient and families receive&#xD;
           dedicated preoperative counselling including information packets.&#xD;
&#xD;
        2. Preoperative optimization: medical optimization before surgery, including renal,&#xD;
           pulmonary, and endocrine function.&#xD;
&#xD;
        3. Smoking and alcohol cessation: smoking and alcohol cessation advised and promoted before&#xD;
           surgery.&#xD;
&#xD;
        4. Preoperative nutrition status: patients screened for nutritional status and counselling&#xD;
           given for a protein-rich diet at least the week before the surgery.&#xD;
&#xD;
      II. PREOPERATIVE PHASE: 2 DAYS BEFORE SURGERY&#xD;
&#xD;
        1. Preoperative fasting and carbohydrate treatment: patients are kept NPO 8h before surgery&#xD;
           except for oral carbohydrate beverage given 2-4h before surgery.&#xD;
&#xD;
        2. Reviewed all examination results: cardiac echography, X-ray, biology's tests&#xD;
&#xD;
        3. Consents signed.&#xD;
&#xD;
        4. Authorization operative be signed&#xD;
&#xD;
        5. Preoperative multimodal analgesic initiated : before surgery 2 h Gabapentin: 600 mg&#xD;
           (P.O) Acetaminophen: 500 mg (P.O) Hydroxyzine: 50 mg (P.O)&#xD;
&#xD;
      III. INTRAOPERATIVE PHASE:&#xD;
&#xD;
        1. Monitoring: Usual Monitoring for Open heart surgery plus a pain monitor Ani&#xD;
&#xD;
           •&#xD;
&#xD;
        2. Anesthesia:&#xD;
&#xD;
           Drugs Ketamine Ketamin: 0,10 mg/kg (bolus) then 0.10 mcg/kg/h Propofol TCI mode Target&#xD;
           Entropy from 40-60 Sufentanil 1 mcg/kg (bolus for Intubation) then 0,1-1 mcg/kg/min (50&#xD;
           &lt; ANI , 70) Esmeron 0.6 - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h 0.6&#xD;
           - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h Esomeprazole 40 mg (IV)&#xD;
           Dexamethasone 0.1 mg/kg Magnesium 10 mg/kg then 10 mg/kg/h Antibio-prophylaxy Cefazolin&#xD;
           2g (IV) or vancomycin 15 mg/kg before incision 1 hours.&#xD;
&#xD;
           erector spinae plane (ESP) block insertion cathter 30 - 40 kg = 6 mL / side 40 - 50 kg =&#xD;
           8 mL / side 50 - 60 kg = 10 mL / side 60 - 70 kg = 12 mL / side &gt; 70 kg = 14 mL / side&#xD;
&#xD;
           Tramexamic Acid 2 g ( IV) 2 g (IV) Heparin 3mg/kg (bolus in Central line), 25 mg in By&#xD;
           Pass 3mg/kg (bolus in Central line), 25 mg in By Pass&#xD;
&#xD;
           ESP catheter Performance (Kit epidural for adult Tuohy needle 19 G Catheter 20G) It is&#xD;
           strictly forbidden to withdraw the inserted catheter throw the needle. If you need to&#xD;
           retrieve the catheter you must retrieve the needle with the catheter.&#xD;
&#xD;
           Patient in Right Lateral decubitus only if Hemodynamic stable US control of needle tip&#xD;
           (dextrose 5%) Insertion of Catheter 20G under US visualization Tip to the top of the&#xD;
           next transverse process Test the catheter with dextrose and see the spread of the liquid&#xD;
           under US guidance in the interfascial space anterior to the ES muscle.&#xD;
&#xD;
             -  Induction 30 min before incision&#xD;
&#xD;
             -  Identify the 2 catheters by Yellow labels (Regional analgesia code)&#xD;
&#xD;
             -  No Variation of BP during sternotomy = ESP efficient If not Sufentanil Bolus&#xD;
&#xD;
           Coagulation test before to start By Pass ACT &gt; 400 secondes BEFORE start by pass .&#xD;
           Inform Surgeon (Do NOT START If NOT)&#xD;
&#xD;
        3. Cardiac by pass:&#xD;
&#xD;
           • Cannulation Time Aortic Y cave Venous Sup and Inf or AtrioCave Connection to By Pass&#xD;
           Air Lock Start By Pass = Volume 950-1000 ml (Ringer lactate, Gelofusine, Mannitol &amp;t&#xD;
           Natri bicarbonate.); Aortic clamp; Cardioplegia Type Cold: crystalloid 4-8 degree&#xD;
           celsius (CUSTODIOL);&#xD;
&#xD;
           Anaesthesia Action:&#xD;
&#xD;
           Stop Ventilation disconnect ETtube/ VA Circuit only when Bypass provide a full&#xD;
           hemodynamic CO= 2.4.BSA l/m2.min. in and out (message FULL FLOW from perfusionist)&#xD;
&#xD;
           Maintenance anesthesia depth by ENTROPY 40-60, ANI &gt;40 Perfusionist targets MAP 50-80&#xD;
           mmHg , CO = 2, 4. BSA (L/m2.min.) SVO2 &gt; 75% Blood tests /30 mn (ABG , lactate, Hb,&#xD;
           Glycemie, ACT with heparin reinjection )&#xD;
&#xD;
        4. Before Getting Out Of By Pass:&#xD;
&#xD;
             -  Anaesthesia Actions Ventilation&#xD;
&#xD;
             -  Restart Ventilation + Reconnect ETtube-&gt; VA Circuit&#xD;
&#xD;
             -  Recruitment Manoeuvers low pressure Temperature and warming Cross clamp time Rhythm&#xD;
                Monitoring Turn on the alarms De-Airing manoeuvres by surgeon &amp; by anesthesiologist&#xD;
                with Control by TEE. Evaluation the result of surgeon and EF before decision to use&#xD;
                inotropes or not.&#xD;
&#xD;
             -  Removal Aortic Clamp and spontaneous defibrillation&#xD;
&#xD;
             -  Perfusion and vaso active drugs assistance SVR - MAP- CVP -CI-SVRI-SVV&#xD;
&#xD;
             -  Inotropes - Vasoconstrictors - Volemia&#xD;
&#xD;
             -  Removal Veinous Canule&#xD;
&#xD;
        5. After Bypass:&#xD;
&#xD;
             -  Test de pace-maker&#xD;
&#xD;
             -  Protamin: Slow IV protamine (dose protamine = dose heparin Total given)&#xD;
&#xD;
             -  Transamin : 2g (IV)&#xD;
&#xD;
             -  Ondansetron 4 mg (IV) - PONV prophylaxy&#xD;
&#xD;
             -  Blood tests 15 min after protamin: ABG Lactate, APTT, PT, FIBRINOGEN, Hb, Glycemia,&#xD;
                NFS,&#xD;
&#xD;
             -  ACT to base line : 120-130 if not =&gt; More protamine&#xD;
&#xD;
             -  Blood transfusion if Hb &lt; 10g/dL or Hct &lt; 30%&#xD;
&#xD;
             -  Platelet transfusion if PLT&lt; 80 000&#xD;
&#xD;
             -  Plasma fresh frozen transfusion if TP &lt; 50%&#xD;
&#xD;
             -  Drains check.&#xD;
&#xD;
             -  Check coagulation total and blood gaz test&#xD;
&#xD;
             -  Ventilation recruitments manoeuvres&#xD;
&#xD;
      IV. POSTOPERATIVE PHASE:&#xD;
&#xD;
        1. CICU transfer:&#xD;
&#xD;
           According to guidelines intubated ventilated patient transfer.&#xD;
&#xD;
        2. CICU:&#xD;
&#xD;
           • Information according to guidelines Reception patient from OT&#xD;
&#xD;
           • Identification of the 2 regional analgesia ESP catheters (Yellow Labels)&#xD;
&#xD;
           • Drains check&#xD;
&#xD;
           • Blood test on arrival ABG , Lactate, Hb, Glycemia, NFS, RP, ECG at arrival CICU&#xD;
&#xD;
           • ABG, glycemie repeat every 4 hours&#xD;
&#xD;
           • Sedation : Stable patient propofol 30-50 mg/h for 2 hours and stop when weaning&#xD;
           criteria riched&#xD;
&#xD;
           • Protocol for analgesia:&#xD;
&#xD;
           all groups&#xD;
&#xD;
           Paracetamol 1g/6h (infusion) Ketorolac 30 mg/8h Nefopam 100 mg/24h&#xD;
&#xD;
           ESP Catheter with analgesia solution Micrel Pumps with intermittent automatic bolus&#xD;
           (IAB) connected and started at T0&#xD;
&#xD;
           Pump preparation and settings:&#xD;
&#xD;
           -Patient 30 - 40 kg = 6 mL / side/6h&#xD;
&#xD;
           -Patient 40 - 50 kg = 8 mL / side/6h&#xD;
&#xD;
             -  Patient 50 - 60 kg = 10 mL/ side/6h&#xD;
&#xD;
             -  Patient 60 - 70 kg = 12 mL/ side/6h&#xD;
&#xD;
             -  Patient &gt; 70 kg = 14 mL / side/6h The bolus on the second catheter will be delayed&#xD;
                by 1 hour Intermittent programmed bolus every 6h&#xD;
&#xD;
           Rescue analgesia Morphine 50 mcg/kg/min if FLACC &gt;3 or ANI &lt; 40&#xD;
&#xD;
           • Fluid management: goal directed fluid therapy (GDFT) controlled by hemodynamics&#xD;
           monitoring (Flotrac): CI, SVV, SVRI, CVP.&#xD;
&#xD;
           Glucose 5%: 01 ml/kg/h + electrolyte balance. Bilan import, export/ 6hours • Early&#xD;
           extubation: (criteria weaning and extubation appendix 1)&#xD;
&#xD;
           • Early mobilization: After extubation 4 hours, sitting in bed and moving thoracic.&#xD;
&#xD;
           Analgeia protocle after extubation If Continuous infusion of morphine replace by&#xD;
           Morphine PCA • Concentration Morphine : 50 mg/49 ml + Ketamine 50 mg • Loading dose: 1mg&#xD;
&#xD;
           • PCA dose demand: 1 mg/dose&#xD;
&#xD;
           • Lockout: 10 min&#xD;
&#xD;
           • Continuous rate (basal): 0&#xD;
&#xD;
             -  Dose limit (hr): 6mg/hour&#xD;
&#xD;
           Plan with daily goals for time out of bed and distance walked beginning as soon as the&#xD;
           day of surgery.&#xD;
&#xD;
           • Early feeding: No sonde gastric Prevention PONV Drinking clear liquids after&#xD;
           extubation 4 hours, eating after 6 hours.&#xD;
&#xD;
      4. Criteria drain thoracic removal:&#xD;
&#xD;
        -  Liquid of mediastenal drains = 0 ml/ 2h;&#xD;
&#xD;
        -  No pleural effusion major;&#xD;
&#xD;
        -  No pneumothorax major;&#xD;
&#xD;
        -  ESP catheters removed 4h after drain removal;&#xD;
&#xD;
        -  After ESP catheter removed analgesia in both group only by:&#xD;
&#xD;
      Efferalgan : 15-20 mg/kg/6h (P.O) Ibuprofen : 400 mg/8h (P.O) Gabapentin : 300 mg/6h (P.O) (5&#xD;
      days postop) 5. Discharge from CICU( criteria discharge appendix 1):&#xD;
&#xD;
      • VAS scores at rest and mob during hospitalization&#xD;
&#xD;
        -  VAS scores at rest and mob at 1 month with return to normal activities&#xD;
&#xD;
           6. Pain Evaluation:&#xD;
&#xD;
        -  Patient Intubated scale FLACC , at rest and after pressure on sternum &amp; drain&#xD;
           mobilization every 6 hours&#xD;
&#xD;
        -  Post extubation still drains VAS scale rest and Mob (sitting in bed moving thorax) ASAP&#xD;
           after extubation and every 6h&#xD;
&#xD;
        -  Localization of the pain VAS Sternum Back pain Drains&#xD;
&#xD;
        -  After drains removed VAS rest and Mob ( sitting in bed moving thorax) and pain&#xD;
           localization Pain (VAS rest ) just after Mediastinal drain removal if possible; Pain&#xD;
           (VAS rest and mob every 8 h) in the ward; Pain at one month (VAS rest and mob).&#xD;
&#xD;
           7. Discharge from hospital: (criteria discharge appendix 1)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Surgical team resigned from our hospital&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">August 14, 2023</completion_date>
  <primary_completion_date type="Actual">August 14, 2023</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>
    <intervention_model_description>Randomized Prospective Controled</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of post operative stay in Hospital</measure>
    <time_frame>10 days</time_frame>
    <description>Duration of hospitalisation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of post operative stay in Intensive care unit</measure>
    <time_frame>3 days</time_frame>
    <description>Duration of stay in Intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to 1st mobilisation</measure>
    <time_frame>3 days</time_frame>
    <description>1st Time to stand up out of bed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery</measure>
    <time_frame>1 month</time_frame>
    <description>Quality of recovery using the scale QOR 16</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Open Heart Surgery</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care for peri operative analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral ESP catheters for peri operative regional analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional analgesia</intervention_name>
    <description>Insertion of bilateral ESP catheters</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open heart surgeries: Valvulopathies ( 1-2 valves, repair or replacement)&#xD;
&#xD;
          -  Congenital heart disease (Risk Adjustment in Congenital Heart Surgery Category 1-2 (&#xD;
             VSD, ASD, T4F)&#xD;
&#xD;
          -  NYHA II,&#xD;
&#xD;
          -  Fraction ejection &gt; 50%,&#xD;
&#xD;
          -  PAPS &lt; 50 mmHg.&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age from 18-60 years old.&#xD;
&#xD;
          -  Consent participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal participation.&#xD;
&#xD;
          -  Allergy to LA&#xD;
&#xD;
          -  Severe thoracic Scoliosis&#xD;
&#xD;
          -  Valvulopathies association with :&#xD;
&#xD;
          -  CABG&#xD;
&#xD;
          -  BENTALL procedure&#xD;
&#xD;
          -  Deficit mental&#xD;
&#xD;
          -  Alcoholics,&#xD;
&#xD;
          -  Heroine addicted&#xD;
&#xD;
          -  Insufficient renal&#xD;
&#xD;
          -  liver failure&#xD;
&#xD;
          -  Endocarditis &lt;1 year&#xD;
&#xD;
          -  Stroke &lt;3 months&#xD;
&#xD;
          -  MI &lt;3 months&#xD;
&#xD;
          -  Bloc AV II or III with Pacemaker permanent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Macaire, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vinmec Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VinMec INternational hopspital</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <reference>
    <citation>Noss C, Prusinkiewicz C, Nelson G, Patel PA, Augoustides JG, Gregory AJ. Enhanced Recovery for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2760-2770. doi: 10.1053/j.jvca.2018.01.045. Epub 2018 Jan 31.</citation>
    <PMID>29503121</PMID>
  </reference>
  <reference>
    <citation>Brown JK, Singh K, Dumitru R, Chan E, Kim MP. The Benefits of Enhanced Recovery After Surgery Programs and Their Application in Cardiothoracic Surgery. Methodist Debakey Cardiovasc J. 2018 Apr-Jun;14(2):77-88. doi: 10.14797/mdcj-14-2-77.</citation>
    <PMID>29977464</PMID>
  </reference>
  <reference>
    <citation>Williams JB, McConnell G, Allender JE, Woltz P, Kane K, Smith PK, Engelman DT, Bradford WT. One-year results from the first US-based enhanced recovery after cardiac surgery (ERAS Cardiac) program. J Thorac Cardiovasc Surg. 2019 May;157(5):1881-1888. doi: 10.1016/j.jtcvs.2018.10.164. Epub 2018 Dec 8.</citation>
    <PMID>30665758</PMID>
  </reference>
  <reference>
    <citation>Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.</citation>
    <PMID>30665850</PMID>
  </reference>
  <reference>
    <citation>Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.</citation>
    <PMID>15043239</PMID>
  </reference>
  <reference>
    <citation>Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.</citation>
    <PMID>17006079</PMID>
  </reference>
  <reference>
    <citation>Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.</citation>
    <PMID>28564673</PMID>
  </reference>
  <reference>
    <citation>Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.</citation>
    <PMID>25500688</PMID>
  </reference>
  <reference>
    <citation>Bignami E, Castella A, Allegri M. Postoperative Pain After Cardiac Surgery: An Open Issue. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e24-e25. doi: 10.1053/j.jvca.2017.09.022. Epub 2017 Sep 20. No abstract available.</citation>
    <PMID>29217242</PMID>
  </reference>
  <reference>
    <citation>Carli F, Kehlet H, Baldini G, Steel A, McRae K, Slinger P, Hemmerling T, Salinas F, Neal JM. Evidence basis for regional anesthesia in multidisciplinary fast-track surgical care pathways. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):63-72. doi: 10.1097/AAP.0b013e31820307f7.</citation>
    <PMID>22002193</PMID>
  </reference>
  <reference>
    <citation>Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.</citation>
    <PMID>27616189</PMID>
  </reference>
  <reference>
    <citation>Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.</citation>
    <PMID>23076899</PMID>
  </reference>
  <reference>
    <citation>Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.</citation>
    <PMID>30055991</PMID>
  </reference>
  <reference>
    <citation>Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.</citation>
    <PMID>28097305</PMID>
  </reference>
  <reference>
    <citation>Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394.</citation>
    <PMID>24469618</PMID>
  </reference>
  <reference>
    <citation>Engelman RM, Rousou JA, Flack JE 3rd, Deaton DW, Humphrey CB, Ellison LH, Allmendinger PD, Owen SG, Pekow PS. Fast-track recovery of the coronary bypass patient. Ann Thorac Surg. 1994 Dec;58(6):1742-6. doi: 10.1016/0003-4975(94)91674-8.</citation>
    <PMID>7979747</PMID>
  </reference>
  <reference>
    <citation>Myles PS, Daly DJ, Djaiani G, Lee A, Cheng DC. A systematic review of the safety and effectiveness of fast-track cardiac anesthesia. Anesthesiology. 2003 Oct;99(4):982-7. doi: 10.1097/00000542-200310000-00035. No abstract available.</citation>
    <PMID>14508335</PMID>
  </reference>
  <reference>
    <citation>Sola M, Ramm CJ, Kolarczyk LM, Teeter EG, Yeung M, Caranasos TG, Vavalle JP. Application of a Multidisciplinary Enhanced Recovery After Surgery Pathway to Improve Patient Outcomes After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2016 Aug 1;118(3):418-23. doi: 10.1016/j.amjcard.2016.05.015. Epub 2016 May 14.</citation>
    <PMID>27344271</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vinmec Healthcare System</investigator_affiliation>
    <investigator_full_name>Philippe Macaire</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Erector spinae Catheter</keyword>
  <keyword>Enhanced Recovery after Cardiac Surgery</keyword>
  <keyword>Peri operative regional analgesia for open heart surgery</keyword>
  <keyword>Quality of recovery</keyword>
  <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/NCT04506762
org study id: ESP ERCS
nct id: NCT04506762
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP
      catheters improves the enhanced recovery program after open heart surgeries for the duration
      of hospitalisation, quality of analgesia, Consumption of peri-operative opioids, quality of
      recovery and quality of life.

      Patients will be randomly divided in 2 groups Group 1 With the actual standards of care for
      enhanced recovery after cardiac surgery including opioid sparing peri operative analgesia
      Group 2 With the actual standards of care for enhanced recovery after cardiac surgery
      replacing the opioid analgesia by a peri operative analgesia by bilateral ESP catheters
I. CONSULTING PHASE: 1 WEEK BEFORE SURGERY

        1. Preoperative information, education and counselling: patient and families receive
           dedicated preoperative counselling including information packets.

        2. Preoperative optimization: medical optimization before surgery, including renal,
           pulmonary, and endocrine function.

        3. Smoking and alcohol cessation: smoking and alcohol cessation advised and promoted before
           surgery.

        4. Preoperative nutrition status: patients screened for nutritional status and counselling
           given for a protein-rich diet at least the week before the surgery.

      II. PREOPERATIVE PHASE: 2 DAYS BEFORE SURGERY

        1. Preoperative fasting and carbohydrate treatment: patients are kept NPO 8h before surgery
           except for oral carbohydrate beverage given 2-4h before surgery.

        2. Reviewed all examination results: cardiac echography, X-ray, biology's tests

        3. Consents signed.

        4. Authorization operative be signed

        5. Preoperative multimodal analgesic initiated : before surgery 2 h Gabapentin: 600 mg
           (P.O) Acetaminophen: 500 mg (P.O) Hydroxyzine: 50 mg (P.O)

      III. INTRAOPERATIVE PHASE:

        1. Monitoring: Usual Monitoring for Open heart surgery plus a pain monitor Ani

           •

        2. Anesthesia:

           Drugs Ketamine Ketamin: 0,10 mg/kg (bolus) then 0.10 mcg/kg/h Propofol TCI mode Target
           Entropy from 40-60 Sufentanil 1 mcg/kg (bolus for Intubation) then 0,1-1 mcg/kg/min (50
           < ANI , 70) Esmeron 0.6 - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h 0.6
           - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h Esomeprazole 40 mg (IV)
           Dexamethasone 0.1 mg/kg Magnesium 10 mg/kg then 10 mg/kg/h Antibio-prophylaxy Cefazolin
           2g (IV) or vancomycin 15 mg/kg before incision 1 hours.

           erector spinae plane (ESP) block insertion cathter 30 - 40 kg = 6 mL / side 40 - 50 kg =
           8 mL / side 50 - 60 kg = 10 mL / side 60 - 70 kg = 12 mL / side > 70 kg = 14 mL / side

           Tramexamic Acid 2 g ( IV) 2 g (IV) Heparin 3mg/kg (bolus in Central line), 25 mg in By
           Pass 3mg/kg (bolus in Central line), 25 mg in By Pass

           ESP catheter Performance (Kit epidural for adult Tuohy needle 19 G Catheter 20G) It is
           strictly forbidden to withdraw the inserted catheter throw the needle. If you need to
           retrieve the catheter you must retrieve the needle with the catheter.

           Patient in Right Lateral decubitus only if Hemodynamic stable US control of needle tip
           (dextrose 5%) Insertion of Catheter 20G under US visualization Tip to the top of the
           next transverse process Test the catheter with dextrose and see the spread of the liquid
           under US guidance in the interfascial space anterior to the ES muscle.

             -  Induction 30 min before incision

             -  Identify the 2 catheters by Yellow labels (Regional analgesia code)

             -  No Variation of BP during sternotomy = ESP efficient If not Sufentanil Bolus

           Coagulation test before to start By Pass ACT > 400 secondes BEFORE start by pass .
           Inform Surgeon (Do NOT START If NOT)

        3. Cardiac by pass:

           • Cannulation Time Aortic Y cave Venous Sup and Inf or AtrioCave Connection to By Pass
           Air Lock Start By Pass = Volume 950-1000 ml (Ringer lactate, Gelofusine, Mannitol &t
           Natri bicarbonate.); Aortic clamp; Cardioplegia Type Cold: crystalloid 4-8 degree
           celsius (CUSTODIOL);

           Anaesthesia Action:

           Stop Ventilation disconnect ETtube/ VA Circuit only when Bypass provide a full
           hemodynamic CO= 2.4.BSA l/m2.min. in and out (message FULL FLOW from perfusionist)

           Maintenance anesthesia depth by ENTROPY 40-60, ANI >40 Perfusionist targets MAP 50-80
           mmHg , CO = 2, 4. BSA (L/m2.min.) SVO2 > 75% Blood tests /30 mn (ABG , lactate, Hb,
           Glycemie, ACT with heparin reinjection )

        4. Before Getting Out Of By Pass:

             -  Anaesthesia Actions Ventilation

             -  Restart Ventilation + Reconnect ETtube-> VA Circuit

             -  Recruitment Manoeuvers low pressure Temperature and warming Cross clamp time Rhythm
                Monitoring Turn on the alarms De-Airing manoeuvres by surgeon & by anesthesiologist
                with Control by TEE. Evaluation the result of surgeon and EF before decision to use
                inotropes or not.

             -  Removal Aortic Clamp and spontaneous defibrillation

             -  Perfusion and vaso active drugs assistance SVR - MAP- CVP -CI-SVRI-SVV

             -  Inotropes - Vasoconstrictors - Volemia

             -  Removal Veinous Canule

        5. After Bypass:

             -  Test de pace-maker

             -  Protamin: Slow IV protamine (dose protamine = dose heparin Total given)

             -  Transamin : 2g (IV)

             -  Ondansetron 4 mg (IV) - PONV prophylaxy

             -  Blood tests 15 min after protamin: ABG Lactate, APTT, PT, FIBRINOGEN, Hb, Glycemia,
                NFS,

             -  ACT to base line : 120-130 if not => More protamine

             -  Blood transfusion if Hb < 10g/dL or Hct < 30%

             -  Platelet transfusion if PLT< 80 000

             -  Plasma fresh frozen transfusion if TP < 50%

             -  Drains check.

             -  Check coagulation total and blood gaz test

             -  Ventilation recruitments manoeuvres

      IV. POSTOPERATIVE PHASE:

        1. CICU transfer:

           According to guidelines intubated ventilated patient transfer.

        2. CICU:

           • Information according to guidelines Reception patient from OT

           • Identification of the 2 regional analgesia ESP catheters (Yellow Labels)

           • Drains check

           • Blood test on arrival ABG , Lactate, Hb, Glycemia, NFS, RP, ECG at arrival CICU

           • ABG, glycemie repeat every 4 hours

           • Sedation : Stable patient propofol 30-50 mg/h for 2 hours and stop when weaning
           criteria riched

           • Protocol for analgesia:

           all groups

           Paracetamol 1g/6h (infusion) Ketorolac 30 mg/8h Nefopam 100 mg/24h

           ESP Catheter with analgesia solution Micrel Pumps with intermittent automatic bolus
           (IAB) connected and started at T0

           Pump preparation and settings:

           -Patient 30 - 40 kg = 6 mL / side/6h

           -Patient 40 - 50 kg = 8 mL / side/6h

             -  Patient 50 - 60 kg = 10 mL/ side/6h

             -  Patient 60 - 70 kg = 12 mL/ side/6h

             -  Patient > 70 kg = 14 mL / side/6h The bolus on the second catheter will be delayed
                by 1 hour Intermittent programmed bolus every 6h

           Rescue analgesia Morphine 50 mcg/kg/min if FLACC >3 or ANI < 40

           • Fluid management: goal directed fluid therapy (GDFT) controlled by hemodynamics
           monitoring (Flotrac): CI, SVV, SVRI, CVP.

           Glucose 5%: 01 ml/kg/h + electrolyte balance. Bilan import, export/ 6hours • Early
           extubation: (criteria weaning and extubation appendix 1)

           • Early mobilization: After extubation 4 hours, sitting in bed and moving thoracic.

           Analgeia protocle after extubation If Continuous infusion of morphine replace by
           Morphine PCA • Concentration Morphine : 50 mg/49 ml + Ketamine 50 mg • Loading dose: 1mg

           • PCA dose demand: 1 mg/dose

           • Lockout: 10 min

           • Continuous rate (basal): 0

             -  Dose limit (hr): 6mg/hour

           Plan with daily goals for time out of bed and distance walked beginning as soon as the
           day of surgery.

           • Early feeding: No sonde gastric Prevention PONV Drinking clear liquids after
           extubation 4 hours, eating after 6 hours.

      4. Criteria drain thoracic removal:

        -  Liquid of mediastenal drains = 0 ml/ 2h;

        -  No pleural effusion major;

        -  No pneumothorax major;

        -  ESP catheters removed 4h after drain removal;

        -  After ESP catheter removed analgesia in both group only by:

      Efferalgan : 15-20 mg/kg/6h (P.O) Ibuprofen : 400 mg/8h (P.O) Gabapentin : 300 mg/6h (P.O) (5
      days postop) 5. Discharge from CICU( criteria discharge appendix 1):

      • VAS scores at rest and mob during hospitalization

        -  VAS scores at rest and mob at 1 month with return to normal activities

           6. Pain Evaluation:

        -  Patient Intubated scale FLACC , at rest and after pressure on sternum & drain
           mobilization every 6 hours

        -  Post extubation still drains VAS scale rest and Mob (sitting in bed moving thorax) ASAP
           after extubation and every 6h

        -  Localization of the pain VAS Sternum Back pain Drains

        -  After drains removed VAS rest and Mob ( sitting in bed moving thorax) and pain
           localization Pain (VAS rest ) just after Mediastinal drain removal if possible; Pain
           (VAS rest and mob every 8 h) in the ward; Pain at one month (VAS rest and mob).

           7. Discharge from hospital: (criteria discharge appendix 1)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Prospective Controled
primary purpose: Supportive Care
masking: None (Open Label)
measure: Length of post operative stay in Hospital
time frame: 10 days
description: Duration of hospitalisation
measure: Length of post operative stay in Intensive care unit
time frame: 3 days
description: Duration of stay in Intensive care unit
measure: Time to 1st mobilisation
time frame: 3 days
description: 1st Time to stand up out of bed
measure: Quality of recovery
time frame: 1 month
description: Quality of recovery using the scale QOR 16
arm group label: Control
arm group type: No Intervention
description: Standard of care for peri operative analgesia
arm group label: Intervention
arm group type: Experimental
description: Bilateral ESP catheters for peri operative regional analgesia
intervention type: Procedure
intervention name: Regional analgesia
description: Insertion of bilateral ESP catheters
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Philippe Macaire, MD
role: Principal Investigator
affiliation: Vinmec Healthcare System
facility: 
country: Vietnam
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PMID: 29503121
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PMID: 29977464
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PMID: 30665758
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PMID: 30665850
citation: Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
PMID: 15043239
citation: Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
PMID: 17006079
citation: Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PMID: 28564673
citation: Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.
PMID: 25500688
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PMID: 29217242
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PMID: 22002193
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PMID: 27616189
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PMID: 27344271
responsible party type: Principal Investigator
investigator affiliation: Vinmec Healthcare System
investigator full name: Philippe Macaire
investigator title: MD
sharing ipd: No