Robot-assisted thoracoscopic surgery vs. sternotomy for thymectomy: A systematic review and meta-analysis.
Cheng-Qian Wang, Jie Wang, Fei-Yu Liu...
https://pubmed.ncbi.nlm.nih.gov/36684131Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06545409
Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-25
28
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) to manage postoperative pain, reduce opioid use, minimize respiratory complications, and improve patient satisfaction after robotic thymectomy surgery. This randomized controlled trial compares patients receiving the SPSIP Block with those who do not, focusing on outcomes like pain intensity and quality of recovery. All participants will receive the SPSIP Block guided by ultrasound 15 minutes before surgery. Half the patients will receive 30 ml of 0.25% bupivacaine as active treatment, while the other half will receive a placebo saline solution. All patients will also receive paracetamol and ketorolac at the end of surgery and have access to a patient-controlled analgesia pump with opioids postoperatively. Rescue doses of paracetamol are provided if pain scores remain high. Participants will be assessed for pain levels at multiple times up to 24 hours after surgery, both at rest and during coughing. Researchers will track opioid use, rescue medication, respiratory complications, hospital stay length, and patient satisfaction using the QoR-15 questionnaire. The study maintains blinding for patients and investigators and includes thorough postoperative monitoring to evaluate recovery and safety.
CONDITIONS
Brief Title
Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients affected by thymoma, thymic hyperplasia, or thymic pathologies such as cysts or teratomas
- Patients who have given informed consent to participate in the study
- Adults aged 18 years or older
You will not qualify if you...
- Patients who refuse to participate by not signing the informed consent
- Patients with myasthenia gravis
- Patients with severe obesity (BMI greater than 35)
- Patients with a history of obstructive sleep apnea syndrome (OSAS) with or without CPAP
- Patients classified as ASA class greater than 3
- Patients unable to understand the Numeric Pain Rating Scale or the Patient Controlled Analgesia device
- Patients allergic to analgesic or anesthetic drugs
- Patients on anticoagulant therapy
- Patients with a history of chronic pain
- Patients with infection at the site of SPSIP Block administration
- Patients who had previous thoracic surgery or thoracic trauma with rib fractures on the surgery side
- Patients with chest deformities or neuromuscular diseases affecting normal lung function
- Patients whose surgery is converted to sternotomy thymectomy during the operation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block 15 minutes before surgery, using either 0.25% bupivacaine or a placebo solution. Surgery is performed using robotic-assisted thoracoscopic techniques for thymectomy. Postoperative pain management includes paracetamol, ketorolac, and patient-controlled analgesia with opioids. Rescue analgesics are given if needed based on pain assessments.
1 treatment visit (in-person)
Post-operative Follow-up
Duration - 24 hours after surgery
Participants are monitored for postoperative pain intensity at 0, 2, 6, 12, and 24 hours after surgery. Total opioid and rescue analgesic use, postoperative complications, recovery quality, and length of hospital stay are recorded. The Quality of Recovery 15 questionnaire is administered 24 hours after surgery to assess patient satisfaction.
Multiple assessments during hospital stay within 24 hours
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico A.Gemelli IRCCs
Rome, Italy, 00135
Actively Recruiting
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Research Team
G
Giovanni Punzo, MD
D
Dania Nachira, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Robot-assisted surgery outperforms video-assisted thoracoscopic surgery for anterior mediastinal disease: a multi-institutional study.
Yin-Kai Chao, Jui-Ying Lee, Hung-I Lu...
https://pubmed.ncbi.nlm.nih.gov/38217569Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain.
Serkan Tulgar, Bahadır Ciftci, Ali Ahiskalioglu...
https://pubmed.ncbi.nlm.nih.gov/36883093Efficacy 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.
Onur Avci, Oğuz Gundogdu, Fatih Balci...
https://pubmed.ncbi.nlm.nih.gov/38343684Surgical management of thymic epithelial tumors.
Yasushi Shintani, Soichiro Funaki, Naoko Ose...
https://pubmed.ncbi.nlm.nih.gov/32647929