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Search / Trial NCT06545409

Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Aug 7, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spsip Rats Thymectomy Thymoma

ClinConnect Summary

This clinical trial is studying a new way to manage pain for patients undergoing robotic thymectomy, a type of surgery to remove the thymus gland. Researchers want to see if a specific pain relief method called the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) can effectively reduce pain after surgery, decrease the need for opioid medications, and improve overall patient satisfaction. They will compare patients who receive this block to those who do not, to determine how well it works in helping patients recover.

To participate in this study, patients should be between the ages of 65 and 74 and have certain conditions affecting the thymus, like thymoma or thymic hyperplasia. However, individuals with specific health issues, such as severe obesity or certain neuromuscular diseases, will not be eligible. Those who join the trial can expect to receive either the new pain relief technique or standard care and will be monitored for how well they manage pain after the surgery. It’s important to note that if the surgery needs to be changed to a more invasive procedure during the operation, those patients will be excluded from the study afterward.

Gender

ALL

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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Giovanni Punzo, MD

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Dania Nachira, MD

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported