Clinical trial · Interventional
Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial
NCT06545409CI-TRIAL-00087613SPRATSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locoregional Anesthesia | — | UNRESOLVED | — |
| Postoperative Pain Management | — | UNRESOLVED | — |
| RATS Surgery | — | UNRESOLVED | — |
| Robotic-Assisted Thoracoscopic Surgery | — | UNRESOLVED | — |
| Serratus Posterior Superior Intercostal Plane Block | — | UNRESOLVED | — |
| Thymectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine | Procedure | — | UNRESOLVED |
| Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPSIP group
- description
- Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed by administering 30 ml of 0.25% bupivacaine.
- interventionNames
- Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed using 30 ml of a placebo solution without an active ingredient (0.9% NaCl)
- interventionNames
- Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDWang CQ, Wang J, Liu FY, Wang W. Robot-assisted thoracoscopic surgery vs. sternotomy for thymectomy: A systematic review and meta-analysis. Front Surg. 2023 Jan 6;9:1048547. doi: 10.3389/fsurg.2022.1048547. eCollection 2022. PMID 36684131
- BACKGROUNDChao YK, Lee JY, Lu HI, Tseng YL, Lee JM, Huang WC. Robot-assisted surgery outperforms video-assisted thoracoscopic surgery for anterior mediastinal disease: a multi-institutional study. J Robot Surg. 2024 Jan 13;18(1):21. doi: 10.1007/s11701-023-01745-1. PMID 38217569
- BACKGROUNDTulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb. PMID 36883093
- BACKGROUNDAvci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13. PMID 38343684
- RESULTShintani Y, Funaki S, Ose N, Kanou T, Fukui E, Kimura K, Minami M. Surgical management of thymic epithelial tumors. Surg Today. 2021 Mar;51(3):331-339. doi: 10.1007/s00595-020-02070-y. Epub 2020 Jul 10. PMID 32647929