[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557999":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":40,"locations":49,"responsibleParty":66,"collaborators":47,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":47,"enrollmentInfo":78,"targetDuration":47,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"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)",[19],"Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine","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.",[9],[27],"SPSIP Block with 0.25% bupivacaine",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)","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",[15],[33],"SPSIP Block with placebo solution (0.9% NaCl)",[35,38],{"name":36,"affiliation":5,"role":37},"Giovanni Punzo, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Dania Nachira, MD",[41,46],{"name":36,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","0630153212","+39","giovanni.punzo@policlinicogemelli.it",{"name":39,"role":42,"phone":47,"phoneExt":47,"email":48},null,"dania.nachira@policlinicogemelli.it",[50],{"facility":51,"status":52,"city":53,"state":47,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Fondazione Policlinico A.Gemelli IRCCs","RECRUITING","Rome","00135","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],12.51133,41.89193,{"lat":61,"lon":60},[64],{"name":36,"role":42,"phone":65,"phoneExt":47,"email":45},"0039 0630153212",{"type":67,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100557999","serratus-posterior-superior-intercostal-plane-block-in-robotic-assisted-thymectomy-100557999",false,"NCT06545409","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","SPRATS","Inclusion Criteria:\n\n* Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study by not signing the informed consent;\n* Patients with myasthenia gravis, severe obesity (BMI \\> 35), history of OSAS with or without CPAP;\n* Patients belonging to ASA classes \\> 3, according to the system developed by the American Society of Anesthesiologists;\n* Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;\n* Patients with allergies to analgesic and\u002For anesthetic drugs;\n* Patients on anticoagulant therapy;\n* Patients with a history of chronic pain;\n* Patients with an infection at the site where SPSIPB will be performed;\n* Patients who have had previous thoracic surgery and\u002For thoracic trauma with rib fractures on the side of the surgery;\n* Patients with chest deformities and\u002For neuromuscular diseases that interfere with normal ventilatory function.\n\nAdditionally, patients whose surgery is intraoperatively converted to sternotomy thymectomy will be excluded post-hoc from the study.","ALL","18 Years",{"count":79,"type":80},28,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86,87,88,89,90,91],"RATS Surgery","Thymectomy","Locoregional Anesthesia","Postoperative Pain Management","Serratus Posterior Superior Intercostal Plane Block","Robotic-Assisted Thoracoscopic Surgery",[93,94,95],"SPSIP","RATS Thymectomy","Thymoma","2025-03-20",{"date":98,"type":99},"2025-03-25","ACTUAL",{"date":101,"type":99},"2025-03-01",{"date":103,"type":80},"2026-09-15",{"name":5,"class":6},1]