Pain management technique for robotic thymectomy
Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial
This study is testing a new pain management technique to see if it can help people having robotic thymectomy surgery feel less pain and recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06545409 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with thymoma, thymic hyperplasia, or other thymic pathologies who can provide informed consent.
Not a fit: Patients with myasthenia gravis, severe obesity, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery outcomes for patients undergoing robotic thymectomy.
How similar studies have performed: Other studies have shown promise with similar locoregional anesthesia techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.