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

NCT06070701 | Completed DMC

• 1 other identifier: 21330
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

cardiac surgery; regional anesthesia; nociception; enhanced rehabilitation; erector spinae plane block; superficial parasternal intercostal plane block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Quality of postoperative analgesia

  6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal

• Time to extubation

  up to 24 hours after surgery

• Norepinephrine dose (mcg/kg)

  intraoperative, 6 hours and 12 hours after surgery

• Time to weaning-off norepinephrine

  up to 96 hours after surgery

• Dobutamine dose (mcg/kg)

  intraoperative, 6 hours and 12 hours after surgery

Study Arms (2)

SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)

EXPERIMENTAL

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); Drug: General anesthetic; Drug: Morphine

ERECTOR SPINAE PLANE BLOCK (ESPB)

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block (ESPB); Drug: General anesthetic; Drug: Morphine

Interventions

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.

SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)

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.

ERECTOR SPINAE PLANE BLOCK (ESPB)

General anesthetic DRUG

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

Also known as: NOL-directed general anesthesia

ERECTOR SPINAE PLANE BLOCK (ESPB); SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)

Morphine DRUG

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

Also known as: Postoperative analgesia

ERECTOR SPINAE PLANE BLOCK (ESPB); SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent.
• Elective heart surgery with sternotomy and bypass.
• Hemodynamic stability prior to induction.
• Sinus rhythm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (1)

Cosmin Balan

Bucharest, Sector 2, 022328, Romania

Location

Related Publications (2)

• 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.

  PMID: 36295622 RESULT

• 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.

  PMID: 36837467 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Anesthetics, General; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Serban-Ion Bubenek-Turconi, Professor

  "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Propensity score matching

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 6, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)