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

Analgesia Clinical Trial

— NESP-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06070701
• Other study ID #: 21330
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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.
• 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.

Drug:
• General anesthetic
During general anesthesia, fentanyl is administered according to NOL monitoring.
• Morphine
Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.

Locations

Country	Name	City	State
Romania	Cosmin Balan	Bucharest	Sector 2

Sponsors (1)

Lead Sponsor	Collaborator
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Country where clinical trial is conducted

Romania, 

References & Publications (2)

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 3 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl consumption (µg/kg)	Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index	during intraoperative period
Primary	Morphine consumption (µg/kg)	Postoperative opioid consumption	48 hours after surgery
Secondary	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
Secondary	Time to extubation	Following ICU admission, the time it takes to extubate the patient safely	up to 24 hours after surgery
Secondary	Norepinephrine dose (mcg/kg)	Cumulative dose of Norepinephrine	intraoperative, 6 hours and 12 hours after surgery
Secondary	Time to weaning-off norepinephrine	Following ICU admission, the time it takes to stop norepinephrine administration	up to 96 hours after surgery
Secondary	Dobutamine dose (mcg/kg)	Cumulative dose of Dobutamine	intraoperative, 6 hours and 12 hours after surgery
Secondary	Time to first dose of morphine	Following admission, the time it takes a patient to request morphine rescue analgesia	any time for 48 hours
Secondary	Extubated patients	Number of extubated patients after ICU admission	2 hours after surgery
Secondary	Norepinephrine-free patients	Number of patients without norepinephrine support	2 hours after surgery
Secondary	Morphine-free patients	Number of patients who did not require morphine rescue analgesia	48 hours after surgery