Serratus Posterior Superior Intercostal Plane (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal-VATS.
NCT ID: NCT07250373
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
28 participants
INTERVENTIONAL
2025-08-01
2027-04-30
Brief Summary
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Detailed Description
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All patients will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of surgery, during skin closure. Upon arrival in the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing an opioid-based solution. Patients reporting a Numeric Pain Rating Scale (NPRS) score greater than 4 during postoperative reassessments, despite PCA use, will be administered a rescue analgesic dose of 1000 mg of paracetamol (repeatable after 8 hours, with a maximum of 3000 mg in 24 hours).
Postoperative pain intensity will be assessed by another investigator (Investigator 2) at 0, 2, 6, 12, and 24 hours after surgery using the NPRS, both at rest and during coughing. Total opioid consumption, rescue analgesic use, incidence of postoperative complications, and length of hospital stay will also be recorded.
Twenty-four hours after surgery, Investigator 2 will administer the Quality of Recovery-15 (QoR-15) questionnaire to all patients. The responses will be used to calculate the QoR-15 index, summarizing overall patient satisfaction. Both patients and Investigator 2 will be blinded to the type of block administered, ensuring the study is conducted in a blinded manner.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPSIP group
Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance by the attending anesthesiologist immediately after skin closure and before extubation .
SPSIP block
While the patient is in the lateral decubitus 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 local anesthetic is administered superficially to the intercostal muscle.
ICN group
Patients in this group will be treated with the ICN block, administered by the surgeon under direct vision at the end of surgery and immediately before skin closure.
ICN block
The ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII.
Interventions
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SPSIP block
While the patient is in the lateral decubitus 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 local anesthetic is administered superficially to the intercostal muscle.
ICN block
The ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII.
Eligibility Criteria
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Inclusion Criteria
* Patients who have provided informed consent to participate in the study
Exclusion Criteria
* Patients with severe obesity (BMI \> 35), history of OSAS with or without CPAP;
* Patients classified as ASA \> 3, according to the system established by the American Society of Anesthesiologists;
* Patients unable to understand the use 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 undergoing anticoagulant therapy;
* Patients with a history of chronic pain;
* Patients with an infection at the site where SPSIPB or ICNB will be performed;
* Patients with a history of thoracic surgery and/or thoracic trauma with rib fractures on the side of surgery;
* Patients with chest wall deformities and/or neuromuscular diseases that interfere with normal ventilatory function.
Additionally, patients whose surgical procedure is intraoperatively converted to an open pulmonary resection will be excluded post hoc from the study.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giovanni Punzo, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dania Nachira, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Countries
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References
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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.
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.
Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.
Nachira D, Meacci E, Petracca Ciavarella L, Chiappetta M, De Santis G, Ferretti GM, Mastromarino MG, Porziella V, Vita ML, Congedo MT, Cesario A, Ismail M, Gonzalez-Rivas D, Margaritora S. Uniportal video-assisted thoracic surgery Roman experience-a report of the first 16-month Roman experience. J Thorac Dis. 2018 Nov;10(Suppl 31):S3678-S3685. doi: 10.21037/jtd.2018.03.119.
Gonzalez-Rivas D, Paradela M, Fieira E, Velasco C. Single-incision video-assisted thoracoscopic lobectomy: initial results. J Thorac Cardiovasc Surg. 2012 Mar;143(3):745-7. doi: 10.1016/j.jtcvs.2011.07.049. Epub 2011 Aug 25. No abstract available.
Other Identifiers
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7594
Identifier Type: -
Identifier Source: org_study_id
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