Cosmin Balan
Bucharest, Sector 2, 022328, Romania
NCT Number: NCT06070701
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Bucharest, Sector 2, 022328, Romania
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
C4. Postoperative
Extubation criteria
Analgesia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
During general anesthesia, fentanyl is administered according to NOL monitoring.
Other names: NOL-directed general anesthesia
Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.
Other names: Postoperative analgesia
Time frame: during intraoperative period
Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Time frame: 48 hours after surgery
Postoperative opioid consumption
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)
Time frame: up to 24 hours after surgery
Following ICU admission, the time it takes to extubate the patient safely
Time frame: intraoperative, 6 hours and 12 hours after surgery
Cumulative dose of Norepinephrine
Time frame: up to 96 hours after surgery
Following ICU admission, the time it takes to stop norepinephrine administration
Time frame: intraoperative, 6 hours and 12 hours after surgery
Cumulative dose of Dobutamine
Time frame: any time for 48 hours
Following admission, the time it takes a patient to request morphine rescue analgesia
Time frame: 2 hours after surgery
Number of extubated patients after ICU admission
Time frame: 2 hours after surgery
Number of patients without norepinephrine support
Time frame: 48 hours after surgery
Number of patients who did not require morphine rescue analgesia
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Other
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
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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