NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block (NESP-II)

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Superficial Parasternal Block (SIPB); Drug: General anesthetic; Drug: Morphine; Procedure: Erector Spinae Plane Block (ESPB)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Sector 2
    • Bucharest, Sector 2, Romania, 022328
      • Cosmin Balan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB); 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); 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.; Drug: General anesthetic; During general anesthesia, fentanyl is administered according to NOL monitoring.; Other Names: NOL-directed general anesthesia; Drug: Morphine; Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.; Other Names: Postoperative analgesia
Active Comparator: 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.	Drug: General anesthetic; During general anesthesia, fentanyl is administered according to NOL monitoring.; Other Names: NOL-directed general anesthesia; Drug: Morphine; Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.; Other Names: Postoperative analgesia; Procedure: Erector Spinae Plane Block (ESPB); 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.

What is the study measuring?

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
Time to extubation	Following ICU admission, the time it takes to extubate the patient safely	up to 24 hours after surgery
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
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

Collaborators and Investigators

• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Investigators: Study Director: Serban-Ion Bubenek-Turconi, Professor, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Publications and helpful links

General Publications

• Balan C, Tomescu DR, Valeanu L, Morosanu B, Stanculea I, Coman A, Stoian A, Bubenek-Turconi SI. Nociception Level Index-Directed Erector Spinae Plane Block in Open Heart Surgery: A Randomized Controlled Clinical Trial. Medicina (Kaunas). 2022 Oct 16;58(10):1462. doi: 10.3390/medicina58101462.
• Balan C, Tomescu DR, Bubenek-Turconi SI. Nociception Control of Bilateral Single-Shot Erector Spinae Plane Block Compared to No Block in Open Heart Surgery-A Post Hoc Analysis of the NESP Randomized Controlled Clinical Trial. Medicina (Kaunas). 2023 Jan 30;59(2):265. doi: 10.3390/medicina59020265.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; regional anesthesia; nociception; erector spinae plane block; enhanced rehabilitation; superficial parasternal intercostal plane block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Morphine; Anesthetics, General
• Other Study ID Numbers: 21330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No