NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block

Study Overview
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Brief Summary
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This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass.

Detailed Description
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A. Ethics Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment. B. Study enrollment Forty consecutive adult patients scheduled for elective open cardiac surgery under general anesthesia are to receive general anesthesia plus SPIPB. This prospective group of patients will be matched one-to-one to a historical group of 55 patients that underwent open cardiac surgery under general anesthesia combined with ESPB. C. Methods C1. Preinduction 16-G peripheral intravenous cannula and radial artery catheter. Five-lead ECG, pulse oximetry, non-invasive and invasive blood pressure monitoring. Analgesia monitor - the NoL index (PMD200TM, Medasense) finger probe will be connected to the index finger of the non-cannulated hand. Surgical antibiotic prophylaxis (Cefuroxime 1.5g). Stress ulcer prophylaxis (omeprazole 40 mg). C2. Superficial Parasternal Intercostal Plane Block (SPIPB) After induction, skin asepsis with chlorhexidine 2% is performed on the anterior chest wall. A high-frequency linear ultrasound probe is positioned parasagittally, 2 cm from midline, bilaterally, at the level of the 4th rib. A 25-G echogenic block needle is inserted at a 20⁰-30⁰ angle in a caudal-to-cephalad direction until the tip of the needle reaches the interfascial plane between the pectoralis major muscle and the internal intercostal muscle. Correct hydrodissection is first certified using normal saline. Subsequently, ropivacaine 0.5% with dexamethasone 8mg/20ml is used and maximum spread is attained by slowly advancing the needle as the interfascial plane splits up ahead. A maximum dose of 3mg/kg ropivacaine is used, corresponding to 1.5 mg/kg per side (e.g., 20 ml ropivacaine 0.5% / side for a 70kg adult). C3. General anaesthesia Monitoring End tidal CO2 (ETCO2). Bispectral index (BIS) monitoring (target 40-60). The nociception monitor (PMD200TM, Medasense) is started before induction. CVP insertion into the right internal jugular vein under ultrasound guidance. Urinary catheter, rectal temperature probe placement. Induction Propofol 1-1.5 mg/kg or Etomidate 0.2-0.3 mg/kg. Fentanyl 5 mcg/kg. Atracurium 0.5 mg/kg. Maintenance of anaesthesia Sevoflurane in O2 during periods of preserved pulmonary blood flow and mechanical ventilation. Propofol infusion during periods of extracorporeal support. Atracurium 0.2-0.3 mg/kg/h for adequate neuromuscular blockade. Analgesia Analgesic drugs Fentanyl: bolus 1.5 mcg/kg. Paracetamol: 1-gram following induction of general anaesthesia. Analgesia monitoring NoL index provides a multiderivative assessment of nociception before cardiopulmonary bypass (CPB) initiation. Optimal analgesia is defined as a NoL index of 10-25. Mean arterial blood pressure (MAP) provides post-CPB decision loop: targets are within ± 15% of MAP recorded during optimum NOL. C4. Postoperative Extubation criteria Normothermia (T◦ ≥ 36◦C). No clinical bleeding. Wakefulness. Hemodynamic stability (MAP ≥ 60 mmHg and lactate ≤ 2 mmol/L) with minimal vasoactive support (dobutamine < 5 µg/kg/min and norepinephrine < 100 ng/kg/min). Adequate gas exchange: Tidal volume ≥ 5 ml/kg. Adequate airway reflex to handle secretions. Analgesia Paracetamol 1g iv every 6 hours. Morphine bolus 0.03 mg/kg for NRS > 3.

Official Title
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NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Open Heart Surgery With Cardiopulmonary Bypass - A Propensity Matched Non-Inferiority Clinical Trial

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Superficial Parasternal Block (SIPB)
* Procedure: Erector Spinae Plane Block (ESPB)
* Drug: General anesthetic
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent. Elective heart surgery with sternotomy and bypass. Hemodynamic stability prior to induction. Sinus rhythm. Exclusion Criteria: Known allergy to any of the medications used in the study. BMI > 35. Patient refusal to participate in the study. Coagulopathy (INR > 1.5, APTT > 45, Fibrinogen < 150 mg/dl). Non-elective/emergent and/or redo surgery. ASA ≥ 4. Any preoperative hemodynamic support (mechanical or pharmaceutical). Severe LV dysfunction (LVEF ≤ 30%). Severe RV dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Propensity score matching
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)<br>Following induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance in the plane between the intercostal muscles and the pectoralis major muscles, targeting the anterior cutaneous branches of the intercostal nerves. | Procedure: Superficial Parasternal Block (SIPB)<br>* Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the superficial parasternal intercostal plane using real-time ultrasound guidance.<br>Drug: General anesthetic<br>* During general anesthesia, fentanyl is administered according to NOL monitoring.<br>* Other names: NOL-directed general anesthesia;Drug: Morphine<br>* Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.<br>* Other names: Postoperative analgesia;|
| Active Comparator: ERECTOR SPINAE PLANE BLOCK (ESPB)<br>Before induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance between the transverse process of the 5th thoracic vertebra and the erector spinae muscle, targeting the dorsal and ventral rami of the spinal nerves. | Procedure: Erector Spinae Plane Block (ESPB)<br>* Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the plane deep to the erector spinae muscle, typically at the level of the 5th thoracic vertebra, under real-time ultrasound guidance.<br>Drug: General anesthetic<br>* During general anesthesia, fentanyl is administered according to NOL monitoring.<br>* Other names: NOL-directed general anesthesia;Drug: Morphine<br>* Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.<br>* Other names: Postoperative analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption (µg/kg) | Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index | during intraoperative period | 
| Morphine consumption (µg/kg) | Postoperative opioid consumption | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of postoperative analgesia | Assessment - numerical rating scale (NRS) (minimum of 0, maximum of 10) | 6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal | 
| Time to extubation | Following ICU admission, the time it takes to extubate the patient safely | up to 24 hours after surgery | 
| Norepinephrine dose (mcg/kg) | Cumulative dose of Norepinephrine | intraoperative, 6 hours and 12 hours after surgery | 
| Time to weaning-off norepinephrine | Following ICU admission, the time it takes to stop norepinephrine administration | up to 96 hours after surgery | 
| Dobutamine dose (mcg/kg) | Cumulative dose of Dobutamine | intraoperative, 6 hours and 12 hours after surgery | 
| Time to first dose of morphine | Following admission, the time it takes a patient to request morphine rescue analgesia | any time for 48 hours | 
| Extubated patients | Number of extubated patients after ICU admission | 2 hours after surgery | 
| Norepinephrine-free patients | Number of patients without norepinephrine support | 2 hours after surgery | 
| Morphine-free patients | Number of patients who did not require morphine rescue analgesia | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, regional anesthesia, nociception, enhanced rehabilitation, erector spinae plane block, superficial parasternal intercostal plane block