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

NCT06070701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-29

No results posted yet for this study

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

Interventions

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.

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.

DRUG

General anesthetic

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

DRUG

Morphine

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Serban-Ion Bubenek-Turconi, Professor · "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-03-01
Completion
2024-04-01

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070701 on ClinicalTrials.gov