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Completed

NCT Number: NCT06070701

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosmin Balan

Bucharest, Sector 2, 022328, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Superficial Parasternal Block (SIPB)

Procedure

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)

Procedure

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.

General anesthetic

Drug

During general anesthesia, fentanyl is administered according to NOL monitoring.

Other names: NOL-directed general anesthesia

Morphine

Drug

Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.

Other names: Postoperative analgesia

Primary outcomes

  1. Fentanyl consumption (µg/kg)

    Time frame: during intraoperative period

    Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index

  2. Morphine consumption (µg/kg)

    Time frame: 48 hours after surgery

    Postoperative opioid consumption

Secondary outcomes

  1. Quality of postoperative analgesia

    Time frame: 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)

  2. Time to extubation

    Time frame: up to 24 hours after surgery

    Following ICU admission, the time it takes to extubate the patient safely

  3. Norepinephrine dose (mcg/kg)

    Time frame: intraoperative, 6 hours and 12 hours after surgery

    Cumulative dose of Norepinephrine

  4. Time to weaning-off norepinephrine

    Time frame: up to 96 hours after surgery

    Following ICU admission, the time it takes to stop norepinephrine administration

  5. Dobutamine dose (mcg/kg)

    Time frame: intraoperative, 6 hours and 12 hours after surgery

    Cumulative dose of Dobutamine

  6. Time to first dose of morphine

    Time frame: any time for 48 hours

    Following admission, the time it takes a patient to request morphine rescue analgesia

  7. Extubated patients

    Time frame: 2 hours after surgery

    Number of extubated patients after ICU admission

  8. Norepinephrine-free patients

    Time frame: 2 hours after surgery

    Number of patients without norepinephrine support

  9. Morphine-free patients

    Time frame: 48 hours after surgery

    Number of patients who did not require morphine rescue analgesia

Sponsors and collaborators

Lead sponsor

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Other

Registry information

Official study 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

Acronym: NESP-II

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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