[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630143":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":61,"collaborators":29,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":29,"maxAge":29,"enrollmentInfo":74,"targetDuration":29,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":29,"overallStatus":83,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Ente Ospedaliero Ospedali Galliera","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Thoracic Erector Spinae Plane Block (ESPB-T)","ACTIVE_COMPARATOR","Patients randomized to this arm receive a bilateral ultrasound-guided thoracic ESPB (T10-T11) in addition to standardized general anesthesia.",[13],"Procedure: Thoracic Erector Spinae Plane Block (ESPB-T)",{"label":15,"type":10,"description":16,"interventionNames":17},"Rectus Sheath Block (RSB)","Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia.",[18],"Procedure: Rectus Sheath Block (RSB)",{"label":20,"type":10,"description":21,"interventionNames":22},"Low-dose Spinal Analgesia (SA)","Patients randomized to this arm receive low-dose intrathecal morphine as part of a spinal analgesic technique, in combination with standardized general anesthesia.",[23],"Procedure: Low-dose Spinal Analgesia (SA)",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","This technique aims to provide both somatic and visceral analgesia through paravertebral spread of local anesthetic, potentially improving control of abdominal and pelvic pain while reducing opioid consumption and opioid-related side effects.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"The RSB primarily targets anterior abdominal wall pain, particularly at laparoscopic port sites, and is intended to reduce postoperative parietal pain and opioid requirements while maintaining a favorable safety profile.",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"This approach provides rapid and effective analgesia with a strong opioid-sparing effect and is commonly used to optimize early postoperative pain control, while carefully monitoring for opioid-related adverse effects.",[20],[37],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},"Marco Micali, MD","CONTACT","00393479980718","marco.micali@galliera.it",[43],{"facility":44,"status":29,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Galliera Hospital","Genova","Ge","16128","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],11.87211,45.21604,{"lat":54,"lon":53},[57,58],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},{"name":59,"role":60,"phone":29,"phoneExt":29,"email":29},"Claudia Brusasco, MD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Marco Micali","Principal investigator","100630143","analgesic-techniques-for-robotic-prostatectomy-procedures-100630143",false,"NCT07483840","Analgesic Techniques for Robotic Prostatectomy Procedures","Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.","PROPAIN","Inclusion Criteria:\n\n* Adult patients scheduled for elective robot-assisted radical prostatectomy or robot-assisted simple prostatectomy\n* Presence of a clinical indication for robot-assisted prostate surgery\n* American Society of Anesthesiologists (ASA) physical status ≥ II\n* Ability to understand the study procedures and provide written informed consent\n* Agreement to participate in the study and compliance with study procedures\n\nExclusion Criteria:\n\n* Patients undergoing open (laparotomic) or emergency surgery\n\nContraindications to central or loco-regional anesthesia techniques, including but not limited to:\n\n* Coagulation disorders or ongoing anticoagulation incompatible with neuraxial or regional anesthesia\n* Known allergy or hypersensitivity to local anesthetics or study drugs\n* Severe spinal deformities\n* Severe aortic stenosis\n* Systemic sepsis or infection at the site of needle insertion\n\nRefusal or inability to provide informed consent","MALE",{"count":75,"type":76},147,"ESTIMATED","INTERVENTIONAL",[79],"NA","Robot-assisted radical prostatectomy and robot-assisted simple prostatectomy are minimally invasive procedures associated with reduced postoperative pain compared to open surgery. However, effective postoperative analgesia remains crucial to optimize recovery, reduce opioid consumption, minimize postoperative nausea and vomiting (PONV), and support early mobilization within Enhanced Recovery After Surgery (ERAS) pathways.\n\nSeveral loco-regional analgesic techniques have been proposed as alternatives to epidural analgesia, including thoracic Erector Spinae Plane Block (ESPB), Rectus Sheath Block (RSB), and low-dose intrathecal (spinal) analgesia. These techniques differ in their mechanisms of action, invasiveness, and potential impact on somatic and visceral pain control.\n\nThis prospective, randomized, single-center study aims to compare the analgesic efficacy and postoperative recovery profiles of three loco-regional analgesic strategies in patients undergoing robot-assisted radical prostatectomy or robot-assisted simple prostatectomy. A total of 147 patients will be randomized to receive thoracic ESPB, bilateral RSB or low-dose spinal analgesia, in combination with standardized general anesthesia according to institutional ERAS protocols.\n\nPrimary outcome is postoperative pain assessed using the Numerical Rating Scale (NRS). Secondary outcomes include opioid and antiemetic rescue requirements, incidence of PONV, time to recovery of oral intake and mobilization, length of hospital stay, and short- and medium-term postoperative complications, with follow-up up to 30 days after surgery.",[82],"Postoperative Analgesia","NOT_YET_RECRUITING","2026-03-17",{"date":86,"type":87},"2026-03-19","ACTUAL",{"date":89,"type":76},"2026-07-01",{"date":91,"type":76},"2028-12-01",{"name":5,"class":6},1]