Pain management technique for robotic thymectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) in managing postoperative pain for patients undergoing robotic thymectomy. Patients will be randomly assigned to receive either the SPSIP Block with bupivacaine or a placebo saline solution before surgery. The study aims to reduce opioid consumption, minimize respiratory complications, and improve patient satisfaction, measured by the QoR-15 index. Data will be collected postoperatively to assess pain levels and overall recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Policlinico A.Gemelli IRCCs
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Giovanni Punzo, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Giovanni Punzo, MD
• Email: giovanni.punzo@policlinicogemelli.it
• Phone: 0630153212

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.