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Recruiting Not applicable

Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy

NCT06545409 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2025-03-25

Condition(s) studied

RATS SurgeryThymectomyLocoregional AnesthesiaPostoperative Pain ManagementSerratus Posterior Superior Intercostal Plane BlockRobotic-Assisted Thoracoscopic Surgery

Investigational drug(s) / intervention(s)

Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaineUltrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)

Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine: While 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): While 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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study. Exclusion Criteria: * 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; * Patients with allergies to analgesic and/or anesthetic drugs; * Patients on anticoagulant therapy; * Patients with a history of chronic pain; * Patients with an infection at the site where SPSIPB will be performed; * Patients who have had previous thoracic surgery and/or thoracic trauma with rib fractures on the side of the surgery; * Patients with chest deformities and/or neuromuscular diseases that interfere with normal ventilatory function. Additionally, patients whose surgery is intraoperatively converted to sternotomy thymectomy will be excluded post-hoc from the study.

Primary outcome measure(s)

  • Postoperative pain intensity — 0, 2, 6, 12, and 24 hours after the end of the surgical procedure
    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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico A.Gemelli IRCCs Rome Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06545409 on ClinicalTrials.gov ↗ ← All trials in Italy