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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: Erector Spinae Plane Block (ESPB); Procedure: Superficial Parasternal Block (SIPB); Drug: General anesthetic; Drug: Morphine

• Registration Number: NCT06070701
• Lead Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Brief Summary

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

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

1. Analgesic drugs

* Fentanyl: bolus 1.5 mcg/kg.

* Paracetamol: 1-gram following induction of general anaesthesia.

2. 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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-01
• Study First Posted: 2023-10-06
• Primary Completion: 2024-03-01
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Informed Consent.
2. Elective heart surgery with sternotomy and bypass.
3. Hemodynamic stability prior to induction.
4. Sinus rhythm.

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Exclusion Criteria

1. Known allergy to any of the medications used in the study.
2. BMI > 35.
3. Patient refusal to participate in the study.
4. Coagulopathy (INR > 1.5, APTT > 45, Fibrinogen < 150 mg/dl).
5. Non-elective/emergent and/or redo surgery.
6. ASA ≥ 4.
7. Any preoperative hemodynamic support (mechanical or pharmaceutical).
8. Severe LV dysfunction (LVEF ≤ 30%).
9. Severe RV dysfunction.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERECTOR SPINAE PLANE BLOCK (ESPB)	Erector Spinae Plane Block (ESPB)	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.
ERECTOR SPINAE PLANE BLOCK (ESPB)	General anesthetic	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.
ERECTOR SPINAE PLANE BLOCK (ESPB)	Morphine	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.
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)	Superficial Parasternal Block (SIPB)	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.
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)	General anesthetic	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.
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)	Morphine	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.

Primary Outcome Measures

Name	Time	Method
Fentanyl consumption (µg/kg)	during intraoperative period	Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Morphine consumption (µg/kg)	48 hours after surgery	Postoperative opioid consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cosmin Balan; 🇷🇴 Bucharest, Sector 2, Romania