About this trial
This study aims to compare two loco-regional analgesic techniques:
1. Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces. 2. Ultrasound-guided ESPB: Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
This protocol is intended for patients undergoing video-assisted thoracoscopic surgery (VATS) for pneumonectomies, lobectomies, wedge resections, and bullectomies.
Primary Endpoint:QoR Score at 24 hours (validated questionnaires. Secondary Endpoints: Intraoperative NOL, QoR at 48-72 hours, opioid consumption at 12-24-48 hours, NLR at 24 hours, CPSP incidence at 3 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Signed informed consent
Elective unilateral surgery
Disqualifiers
Minor patients
BMI > 40
Unstable neurological disorders
Known allergy to acetaminophen and NSAIDs
Trial design
Parallel
Treatments tested in this trial
Intercostal nerve block
Procedure/SurgeryBefore final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.
Ultrasound-guided ESPB
Procedure/SurgeryAfter identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
Treatment groups
Trial outcomes
Primary outcomes
QoR Score at Day 1
Secondary outcomes
Intraoperative NOL (Nociception Level Index®)
NOL (Nociception Level) is the technology and index to objectively quantify a patient's physiological pain response (nociception). The Nociception Level index (NOL™) is a multiparameter index, based on artificial intelligence for the monitoring of nociception during anesthesia. We record the NOL number to assess nociceptive stimulation during surgery.
Locations
Sponsors and contacts
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ASST Sette Laghi
Lead sponsor
Ospedale di Circolo - Fondazione Macchi
Sponsor institution
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