Clinical trial NCT04506762: Benefit of Peri-operative Bilateral ESP Catheters for Enhanced Recovery for Cardiac Surgery (ERCS)
Official title: Does Bilateral Continuous Peri Operative Erector Spinae Plane Block Improve The Enhanced Recovery Program After Open Heart Surgeries in Adults?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open Heart Surgery
Keywords: Erector spinae Catheter
Enhanced Recovery after Cardiac Surgery
Peri operative regional analgesia for open heart surgery
Quality of recovery
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Prospective Controled
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Open heart surgeries: Valvulopathies ( 1-2 valves, repair or replacement)
* Congenital heart disease (Risk Adjustment in Congenital Heart Surgery Category 1-2 ( VSD, ASD, T4F)
* NYHA II,
* Fraction ejection \> 50%,
* PAPS \< 50 mmHg.
* Male
* Female
* Age from 18-60 years old.
* Consent participation

Exclusion Criteria:

* Refusal participation.
* Allergy to LA
* Severe thoracic Scoliosis
* Valvulopathies association with :
* CABG
* BENTALL procedure
* Deficit mental
* Alcoholics,
* Heroine addicted
* Insufficient renal
* liver failure
* Endocarditis \<1 year
* Stroke \<3 months
* MI \<3 months
* Bloc AV II or III with Pacemaker permanent

Primary outcomes:
measure: Length of post operative stay in Hospital
timeFrame: 10 days
Secondary outcomes:
measure: Length of post operative stay in Intensive care unit
timeFrame: 3 days
measure: Time to 1st mobilisation
timeFrame: 3 days
measure: Quality of recovery
timeFrame: 1 month
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VinMec INternational hopspital
Study officials:
affiliation: Vinmec Healthcare System
name: Philippe Macaire, MD
role: PRINCIPAL_INVESTIGATOR
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