Clinical trial NCT06070701: NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: cardiac surgery
regional anesthesia
nociception
enhanced rehabilitation
erector spinae plane block
superficial parasternal intercostal plane block
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Propensity score matching
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fentanyl consumption (µg/kg)
timeFrame: during intraoperative period
measure: Morphine consumption (µg/kg)
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Quality of postoperative analgesia
timeFrame: 6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal
measure: Time to extubation
timeFrame: up to 24 hours after surgery
measure: Norepinephrine dose (mcg/kg)
timeFrame: intraoperative, 6 hours and 12 hours after surgery
measure: Time to weaning-off norepinephrine
timeFrame: up to 96 hours after surgery
measure: Dobutamine dose (mcg/kg)
timeFrame: intraoperative, 6 hours and 12 hours after surgery
measure: Time to first dose of morphine
timeFrame: any time for 48 hours
measure: Extubated patients
timeFrame: 2 hours after surgery
measure: Norepinephrine-free patients
timeFrame: 2 hours after surgery
measure: Morphine-free patients
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Cosmin Balan
state: Sector 2
Study officials:
affiliation: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
name: Serban-Ion Bubenek-Turconi, Professor
role: STUDY_DIRECTOR
References:
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):1462. doi: 10.3390/medicina58101462.
citation: 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.