Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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
Induction
Maintenance of anaesthesia
Analgesia
Analgesic drugs
Analgesia monitoring
C4. Postoperative
Extubation criteria
Analgesia
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to extubation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Serban-Ion Bubenek-Turconi, Professor | "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmin Balan | Bucharest | Sector 2 | 022328 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36295622 | Result | 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. | |
| 36837467 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Propensity score matching
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| Morphine | Drug | Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4. |
|
|
Following ICU admission, the time it takes to extubate the patient safely
| up to 24 hours after surgery |
| Norepinephrine dose (mcg/kg) | Cumulative dose of Norepinephrine | intraoperative, 6 hours and 12 hours after surgery |
| Time to weaning-off norepinephrine | Following ICU admission, the time it takes to stop norepinephrine administration | up to 96 hours after surgery |
| Dobutamine dose (mcg/kg) | Cumulative dose of Dobutamine | intraoperative, 6 hours and 12 hours after surgery |
| Time to first dose of morphine | Following admission, the time it takes a patient to request morphine rescue analgesia | any time for 48 hours |
| Extubated patients | Number of extubated patients after ICU admission | 2 hours after surgery |
| Norepinephrine-free patients | Number of patients without norepinephrine support | 2 hours after surgery |
| Morphine-free patients | Number of patients who did not require morphine rescue analgesia | 48 hours after surgery |
| 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. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018681 | Anesthetics, General |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided