NCT06545409 Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
| NCT ID | NCT06545409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | RATS Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-03-01 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Giovanni Punzo, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06545409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying RATS Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545409 currently recruiting?
Yes, NCT06545409 is actively recruiting participants. Contact the research team at giovanni.punzo@policlinicogemelli.it for enrollment information.
Where is the NCT06545409 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06545409 clinical trial?
NCT06545409 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Giovanni Punzo, MD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 28 participants.