[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623188":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":57,"studyPopulation":48,"armGroups":58,"interventions":77,"overallOfficials":48,"centralContacts":95,"locations":101,"responsibleParty":115,"collaborators":48,"id":119,"slug":48,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":48,"enrollmentInfo":127,"targetDuration":48,"studyType":130,"phases":131,"briefSummary":57,"conditions":133,"keywords":135,"overallStatus":139,"whyStopped":48,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Curve of Pain Intensity During Coughing","Pain intensity during coughing will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated measurements to reflect overall pain burden during the first 48 hours after surgery. Pain assessments will be performed by trained study evaluators.","1, 2, 6, 12, 24, 36, and 48 hours postoperatively",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Area Under the Curve of Resting Pain Intensity","Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated assessments to evaluate cumulative resting pain during the first 48 hours after surgery. Assessments will be performed by trained study evaluators.",{"measure":18,"description":19,"timeFrame":20},"Postoperative Opioid Consumption","Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed.","Up to 48 hours postoperatively",{"measure":22,"description":23,"timeFrame":24},"Quality of Recovery","Postoperative recovery quality will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40), which evaluates multiple domains of postoperative recovery.","Baseline (preoperative), 24 hours, and 48 hours postoperatively",[26,30,34,37,41],{"measure":27,"description":28,"timeFrame":29},"Plasma Bupivacaine Concentration","Plasma concentrations of bupivacaine will be measured to assess systemic exposure following intrapleural administration. Venous blood samples will be collected at predefined time points and analyzed using validated analytical methods. Concentration-time data will be used to characterize the pharmacokinetic profile.","From pre-administration to 48 hours postoperatively",{"measure":31,"description":32,"timeFrame":33},"Patient Satisfaction With Pain Management","Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied), reflecting overall satisfaction with pain control.","48 hours postoperatively",{"measure":35,"description":36,"timeFrame":20},"Rescue Analgesic Consumption","Total consumption of rescue analgesic medications administered within the first 48 hours after surgery will be recorded and analyzed.",{"measure":38,"description":39,"timeFrame":40},"Postoperative Systemic Inflammatory Response","The postoperative systemic inflammatory response will be assessed as a composite evaluation based on venous blood samples. This assessment will characterize the overall inflammatory response by integrating multiple inflammatory components, including serum cytokine levels (IL-6, IL-8, IL-12, TNF-α), C-reactive protein (CRP), and cellular inflammation indices derived from complete blood count data, including the systemic immune-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR).","Baseline (preoperative) and 24 hours postoperatively",{"measure":42,"description":43,"timeFrame":44},"Adverse Events","All adverse events will be recorded from the time of informed consent through hospital discharge. Adverse event severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, and events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 26.1. Serious adverse events will be followed until resolution, stabilization, or up to 30 days after hospital discharge, whichever occurs first.","From informed consent to hospital discharge (serious adverse events followed up to 30 days post-discharge)",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":48,"timePerspective":48,"maskingInfo":50},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":51,"maskingDescription":48,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited.\n\nThis is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels.\n\nThis study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.",[59,66,71],{"label":60,"type":61,"description":62,"interventionNames":63},"0.25% Bupivacaine Intrapleural Analgesia","EXPERIMENTAL","Participants receive programmed intermittent intrapleural administration of 0.25% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.",[64,65],"Drug: Bupivacaine 0.25%","Other: Multimodal Analgesia",{"label":67,"type":61,"description":68,"interventionNames":69},"0.125% Bupivacaine Intrapleural Analgesia","Participants receive programmed intermittent intrapleural administration of 0.125% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.",[70,65],"Drug: Bupivacaine 0.125%",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo Intrapleural Analgesia (Normal Saline)","PLACEBO_COMPARATOR","Participants receive programmed intermittent intrapleural administration of normal saline via a chest drainage tube connected to a programmed infusion pump as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.",[76,65],"Drug: Normal Saline",[78,83,87,91],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":48},"DRUG","Bupivacaine 0.125%","Bupivacaine 0.125% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.",[67],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":48},"Bupivacaine 0.25%","Bupivacaine 0.25% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.",[60],{"type":79,"name":88,"description":89,"armGroupLabels":90,"otherNames":48},"Normal Saline","Normal saline is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery.",[72],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":48},"Multimodal Analgesia","All participants receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated, in addition to the assigned intrapleural intervention.",[67,60,72],[96],{"name":97,"role":98,"phone":99,"phoneExt":48,"email":100},"Leo Li","CONTACT","021-18621710790","18621710790@163.com",[102],{"facility":103,"status":48,"city":104,"state":48,"zip":48,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Shanghai Pulmonary Hospital","Shanghai","China","CN",{"type":108,"coordinates":109},"Point",[110,111],121.45806,31.22222,{"lat":111,"lon":110},[114],{"name":97,"role":98,"phone":99,"phoneExt":48,"email":100},{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Wei Wu","Attending Physician, Department of Anesthesiology","100623188",false,"NCT07393386","Intrapleural Bupivacaine Analgesia for Postoperative Pain Management After Minimally Invasive Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial","IBVATS","Inclusion Criteria:\n\n1. Patients scheduled for elective video-assisted thoracoscopic surgery\n2. Age≥18 years\n3. American Society of Anesthesiologists (ASA) physical status classification I-III\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. History of chronic pain\n3. History of alcohol or opioid dependence\n4. Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities\n5. Coexisting central nervous system disorders\n6. Hepatic or renal dysfunction\n7. Known hypersensitivity to local anesthetics or opioids\n8. Local infection at or near the planned site of regional anesthesia, or systemic infection\n9. Language impairment or difficulty in communication\n10. Refusal to participate in the study or refusal to use patient-controlled analgesia\n11. Concurrent participation in another clinical trial","ALL","18 Years",{"count":128,"type":129},249,"ESTIMATED","INTERVENTIONAL",[132],"PHASE4",[134],"Pain Management",[136,137,138],"Postoperative pain","Thoracoscopic surgery","Intrapleural analgesia","NOT_YET_RECRUITING","2026-02-01",{"date":142,"type":143},"2026-02-06","ACTUAL",{"date":140,"type":129},{"date":146,"type":129},"2028-06-30",{"name":5,"class":6},1]