Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy

NCT06545409 | Recruiting

• 1 other identifier: 6729
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

RATS Surgery; Thymectomy; Locoregional Anesthesia; Postoperative Pain Management; Serratus Posterior Superior Intercostal Plane Block; Robotic-Assisted Thoracoscopic Surgery

Keywords

SPSIP; RATS Thymectomy; Thymoma

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.

  0, 2, 6, 12, and 24 hours after the end of the surgical procedure

Secondary Outcomes (5)

• Total opioid drug consumption

  24 hours after surgery

• Consumption of rescue analgesics

  24 hours after surgery

• postoperative respiratory complications

  24 hours after surgery

• postoperative quality of recovery

  24 hours after surgery

• Length of Hospital Stay

  from the end of the surgical procedure to patient discharge

Study Arms (2)

SPSIP group

EXPERIMENTAL

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.

Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine

Placebo group

PLACEBO COMPARATOR

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)

Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)

Interventions

Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine PROCEDURE

While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.25% bupivacaine is administered superficially to the intercostal muscle.

Also known as: SPSIP Block with 0.25% bupivacaine

SPSIP group

Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl) PROCEDURE

While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.9% NaCl is administered superficially to the intercostal muscle

Also known as: SPSIP Block with placebo solution (0.9% NaCl)

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico A.Gemelli IRCCs

Rome, 00135, Italy

RECRUITING

Related Publications (5)

• Wang 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 BACKGROUND

• Chao 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 BACKGROUND

• Tulgar 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 BACKGROUND

• Avci 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 BACKGROUND

• Shintani 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 RESULT

MeSH Terms

Conditions

Thymoma

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Giovanni Punzo, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Dania Nachira, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Punzo, MD

CONTACT

0630153212; giovanni.punzo@policlinicogemelli.it

Dania Nachira, MD

CONTACT

dania.nachira@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: March 1, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)