About this trial
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.
Disqualifiers
Patients who refuse to participate in the study by not signing the informed consent;
Patients with myasthenia gravis, severe obesity (BMI > 35), history of OSAS with or without CPAP;
Patients belonging to ASA classes > 3, according to the system developed by the American Society of Anesthesiologists;
Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;
Trial design
Parallel
Treatments tested in this trial
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine
Procedure/SurgeryWhile the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.25% bupivacaine is administered superficially to the intercostal muscle.
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)
Procedure/SurgeryWhile the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.9% NaCl is administered superficially to the intercostal muscle
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain intensity
The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.
Secondary outcomes
Total opioid drug consumption
The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery
Consumption of rescue analgesics
The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours
postoperative respiratory complications
The number of any postoperative respiratory complications in the two study groups
postoperative quality of recovery
the patient's level of satisfaction measured using the QoR-15 index, a numerical parameter calculated by administering the Quality of Recovery 15 (QoR-15) questionnaire to the patient
Sponsors and contacts
Click on the lead sponsor to view all of their trials.