[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610772":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":65,"studyPopulation":53,"armGroups":66,"interventions":80,"overallOfficials":95,"centralContacts":101,"locations":111,"responsibleParty":134,"collaborators":53,"id":137,"slug":53,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":138,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":53,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":113,"whyStopped":53,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Ataturk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of Recovery-15 (QoR-15) Score","The Quality of Recovery-15 (QoR-15) questionnaire is a validated 15-item instrument that assesses patient-centered postoperative recovery, including pain, physical comfort, emotional state, and overall wellbeing. The total score ranges from 0 to 150, with higher scores indicating better recovery.","Measured 24 hours after surgery",[14,18,22,26,30,33,37,40,44,47,50],{"measure":15,"description":16,"timeFrame":17},"Time to First Rescue Opioid","Duration (in hours) from the end of surgery to the first administration of rescue opioid (intravenous tramadol) when the Visual Analog Scale (VAS) pain score exceeds 4.","Within 24 hours postoperatively",{"measure":19,"description":20,"timeFrame":21},"Postoperative Pain Scores (VAS)","Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Both active (movement) and passive (rest) VAS scores will be recorded at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours after surgery. Higher scores indicate more severe pain.","From postoperative hour 2 to hour 24.",{"measure":23,"description":24,"timeFrame":25},"Total Opioid Consumption","Cumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.","24 hours postoperatively",{"measure":27,"description":28,"timeFrame":29},"Intraoperative Complications","Occurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.","During surgery",{"measure":31,"description":32,"timeFrame":25},"Postoperative Adverse Effects","Incidence of nausea, vomiting, pruritus, respiratory depression, or other opioid-related side effects during the first 24 hours postoperatively.",{"measure":34,"description":35,"timeFrame":36},"Serum Interleukin-6 (IL-6) Level","Serum IL-6 levels (pg\u002FmL) will be measured to evaluate the systemic inflammatory response associated with surgical stress.","Preoperatively and at 24 hours postoperatively",{"measure":38,"description":39,"timeFrame":36},"Neutrophil-to-Lymphocyte Ratio (NLR)","The neutrophil-to-lymphocyte ratio (NLR) will be calculated to evaluate postoperative inflammatory status and its correlation with pain intensity and functional recovery.",{"measure":41,"description":42,"timeFrame":43},"Serum C-reactive Protein (CRP) Level","Serum CRP levels (mg\u002FL) will be measured to assess postoperative systemic inflammation.","Preoperatively and at 24 hours postoperatively.",{"measure":45,"description":46,"timeFrame":43},"Platelet-to-Lymphocyte Ratio (PLR)","The platelet-to-lymphocyte ratio (PLR) will be calculated as a marker of postoperative inflammation and its correlation with pain level and recovery quality.",{"measure":48,"description":49,"timeFrame":43},"Lymphocyte-to-Monocyte Ratio (LMR)","The lymphocyte-to-monocyte ratio (LMR) will be calculated to assess systemic immune response in relation to postoperative recovery.",{"measure":51,"description":52,"timeFrame":43},"Systemic Immune-Inflammation Index (SII)","The systemic immune-inflammation index (SII) will be calculated as platelet × neutrophil \u002F lymphocyte, providing an integrated indicator of postoperative inflammatory and immune status.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":53,"timePerspective":53,"maskingInfo":59},"RANDOMIZED","PARALLEL","Patients will be randomized into two groups in a 1:1 ratio: Group ITM + SAPB + Dexmedetomidine and Group SAPB + Dexmedetomidine.","TREATMENT",{"masking":60,"maskingDescription":61,"whoMasked":62},"DOUBLE","Participants and postoperative data collectors will be blinded to group allocation. The anesthesiologist performing the intervention will be aware of the allocation due to the nature of the procedure.",[63,64],"PARTICIPANT","OUTCOMES_ASSESSOR","This is a single-center, prospective, randomized, double-blind clinical trial evaluating the efficacy of intrathecal morphine in combination with serratus anterior plane block (SAPB) and dexmedetomidine infusion for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS). Eligible patients are ASA I-II, aged 18-70 years, with BMI \\\u003C 35 kg\u002Fm². Patients will be randomized into two groups using a computer-generated sequence. The intervention group will receive intrathecal morphine (200 µg) in addition to SAPB and dexmedetomidine, while the control group will receive SAPB and dexmedetomidine alone. The primary outcome is postoperative pain scores (VAS) within the first 24 hours. Secondary outcomes include opioid consumption, quality of recovery, and incidence of side effects.",[67,75],{"label":68,"type":69,"description":70,"interventionNames":71},"ITM + SAPB + Dex","EXPERIMENTAL","Before induction, 200 µg intrathecal morphine via a 27G Sprotte spinal needle from L3-L4; intraoperative 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg\u002Fkg loading (15 min) followed by a 0.5 µg\u002Fkg\u002Fh infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine under ultrasound guidance at the end of surgery; basal tramadol PCA without infusion IV in the PACU (20 mg each bolus, maximum 200 mg\u002F24 h); if necessary, 50 mg tramadol IV for VAS\\>4.",[72,73,74],"Drug: Intrathecal Morphine","Procedure: Serratus Anterior Plane Block (SAPB) group","Drug: Dexmedetomidine",{"label":76,"type":77,"description":78,"interventionNames":79},"SAPB + Dex (No ITM)","ACTIVE_COMPARATOR","Same protocol, but no intrathecal morphine. Intraoperatively, 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg\u002Fkg loading dose (15 min) followed by a 0.5 µg\u002Fkg\u002Fh infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine at the end of surgery; basal intravenous tramadol PCA (20 mg each bolus, maximum 200 mg\u002F24 h) in the PACU; if necessary, 50 mg tramadol IV for VAS \\>4.",[73,74],[81,86,91],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":53},"DRUG","Intrathecal Morphine","200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.",[68],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":53},"PROCEDURE","Serratus Anterior Plane Block (SAPB) group","Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.",[68,76],{"type":82,"name":92,"description":93,"armGroupLabels":94,"otherNames":53},"Dexmedetomidine","Loading dose 0.5 µg\u002Fkg over 15 minutes, then 0.5 µg\u002Fkg\u002Fh continuous infusion intraoperatively.",[68,76],[96,99],{"name":97,"affiliation":5,"role":98},"İREM ATEŞ","PRINCIPAL_INVESTIGATOR",{"name":100,"affiliation":5,"role":98},"Nuray Uzun",[102,107],{"name":103,"role":104,"phone":105,"phoneExt":53,"email":106},"İrem Ateş Associate Professor (Doçent Doktor)","CONTACT","+90 532 740 12 58","driremates@hotmail.com",{"name":108,"role":104,"phone":109,"phoneExt":53,"email":110},"Mehmet Akif Yılmaz, assistant doctor","+90 534 653 35 39","mehmetakifyilmaz025@gmail.com",[112,125],{"facility":5,"status":113,"city":114,"state":53,"zip":115,"country":116,"countryCode":53,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"RECRUITING","Erzurum","25000","Turkey (Türkiye)",{"type":118,"coordinates":119},"Point",[120,121],41.27694,39.90861,{"lat":121,"lon":120},[124],{"name":108,"role":104,"phone":109,"phoneExt":53,"email":110},{"facility":5,"status":113,"city":114,"state":53,"zip":126,"country":116,"countryCode":53,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"25240",{"type":118,"coordinates":128},[120,121],{"lat":121,"lon":120},[131],{"name":132,"role":104,"phone":133,"phoneExt":53,"email":110},"Mehmet Akif Yilmaz","05346533539",{"type":98,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"irem ateş","Principal Investigator İrem Ateş","100610772",false,"NCT07231926","Intrathecal Morphine for Recovery and Outcomes After VATS","The Effects of Intrathecal Morphine in Addition to Serratus Anterior Plane Block and Dexmedetomidine on Postoperative Recovery (QoR-15) and Systemic Inflammation in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial","IMPROVE-VATS","Inclusion Criteria:\n\n* Elective video-assisted thoracoscopic surgery (VATS) planned\n* Age 18-70 years\n* ASA physical status I-III\n* Body mass index (BMI) \\\u003C35 kg\u002Fm²\n\nExclusion Criteria:\n\n* Coagulopathy\n* Opioid dependence or intolerance\n* Allergy to local anesthetics\n* Contraindications to neuraxial blockade\n* Chronic pain history\n* Renal or hepatic failure","ALL","18 Years","70 Years",{"count":148,"type":149},52,"ESTIMATED","INTERVENTIONAL",[152],"NA","This study will compare two different methods of pain management in patients undergoing video-assisted thoracoscopic surgery (VATS). One group will receive a combination of spinal morphine, nerve block, and dexmedetomidine, while the other group will receive a nerve block and dexmedetomidine without spinal morphine. All patients will receive standard pain medications after surgery. The purpose is to see if adding spinal morphine improves pain control and recovery after surgery.",[155],"Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery",[157,158,83,159,160],"Video-Assisted Thoracoscopic Surgery","Postoperative Analgesia","Patient-Controlled Analgesia (PCA)","Thoracic Surgery Pain Management","2026-02-03",{"date":163,"type":164},"2026-02-05","ACTUAL",{"date":166,"type":164},"2025-12-01",{"date":168,"type":149},"2026-06-02",{"name":5,"class":6},2]