[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594356":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":66,"studyPopulation":54,"armGroups":67,"interventions":80,"overallOfficials":89,"centralContacts":93,"locations":101,"responsibleParty":179,"collaborators":181,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":54,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":54,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":104,"whyStopped":54,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of chronic postsurgical pain with functional impact at 3 months after surgery","CPSP is a composite binary endpoint, positive only when all three criteria are met: (1) pain related to thoracoscopic surgery, confirmed by the scripted question \"Do you currently have persisting pain related to your thoracoscopic surgery?\", localized to the surgical site or a referred area, present for at least 3 months, and not attributable to other causes (local infection, tumour recurrence, or a new surgical or medical condition); (2) average numeric rating scale (NRS) pain score \\>= 1 (0-10) at the surgical site during the week preceding the assessment; and (3) pain-related functional interference, defined as a pain interference score \\>= 1 on the Brief Pain Inventory-Short Form (validated Chinese version), calculated as the mean of 7 interference items (each 0-10; prorated mean if at least 4 of 7 items are completed), with a 1-week recall period.","At 3 months after surgery (assessment window: postoperative day 90 +\u002F- 14 days)",[14,18,21,25,29,33,37,40,44,47,50],{"measure":15,"description":16,"timeFrame":17},"Postoperative acute pain NRS score","Acute pain intensity at 24 and 48 hours after surgery, measured by the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse outcomes (greater pain intensity).","24h and 48h after surgery",{"measure":19,"description":20,"timeFrame":17},"Quality of Recovery-15 (QoR-15) score","The QoR-15 assesses postoperative recovery quality across 15 items (0-10 each; total 0-150), administered at the bedside. Higher scores indicate better recovery.",{"measure":22,"description":23,"timeFrame":24},"Cumulative PCA opioid consumption and bolus deliveries","Total delivered volume of the study solution (mL) and number of bolus deliveries (attempted and successful) recorded by the PCA pump during the 48-hour intervention period. Delivered oliceridine and sufentanil doses will be derived from body weight-based concentrations. The cumulative 24-hour oliceridine dose will be documented against the 27 mg\u002Fday threshold specified in the prescribing information.","0-48 hours postoperatively",{"measure":26,"description":27,"timeFrame":28},"Incidence of opioid-related adverse events","Incidence of opioid-related adverse events (ORAEs) within 48 hours postoperatively, including: postoperative nausea and vomiting (PONV), respiratory depression (SpO₂ \\\u003C92% or respiratory rate \\\u003C8\u002Fmin), pruritus, sedation (Ramsay Sedation Scale ≥4), and dizziness.","0-48 h postoperatively",{"measure":30,"description":31,"timeFrame":32},"Use and frequency of rescue analgesic administration","Dose and frequency of rescue analgesics","0-48h postoperatively, 1 month postoperatively, 3 months postoperatively",{"measure":34,"description":35,"timeFrame":36},"Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores","BPI-SF pain severity (mean of 4 items) and pain interference (mean of 7 items) scores, each 0-10, administered by face-to-face interview or structured telephone interview with a 1-week recall period.","1 month postoperatively, 3 months postoperatively",{"measure":38,"description":39,"timeFrame":36},"Incidence of neuropathic pain component (DN4i ≥ 4)","The 7-item interview version of the Douleur Neuropathique 4 questionnaire (DN4i, score range 0-7) administered by structured telephone interview. DN4i \\>= 4 indicates the presence of neuropathic pain components.",{"measure":41,"description":42,"timeFrame":43},"Sleep quality assessment","Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rated questionnaire yielding a global score ranging from 0 to 21. Higher scores indicate worse outcomes (poorer sleep quality).","1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively",{"measure":45,"description":46,"timeFrame":43},"Psychological status assessment","Anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire with two 7-item subscales: the HADS-Anxiety subscale and the HADS-Depression subscale, each ranging from 0 to 21. Higher scores indicate worse outcomes (greater anxiety or depressive symptoms).",{"measure":48,"description":49,"timeFrame":43},"Pain catastrophizing level","Pain catastrophizing assessed by the Pain Catastrophizing Scale (PCS), a 13-item self-report questionnaire with a total score ranging from 0 to 52. Higher scores indicate worse outcomes (higher levels of pain catastrophizing).",{"measure":51,"description":52,"timeFrame":53},"Quality of life assessment","Quality of life assessed by the 36-Item Short Form Health Survey (SF-36), which yields 8 domain scores, each transformed to a scale of 0 to 100. Higher scores indicate better outcomes (better health-related quality of life).","1 day preoperatively(baseline), 3 months postoperatively",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":54,"primaryPurpose":58,"observationalModel":54,"timePerspective":54,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":54,"whoMasked":61},"QUADRUPLE",[62,63,64,65],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The primary objective is to evaluate the impact of oliceridine versus sufentanil administered via patient controlled intravenous analgesia (PCIA) for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery. This is a multicentre, randomised, double-blind, controlled trial enrolling 320 patients across seven Chinese tertiary centres.",[68,74],{"label":69,"type":70,"description":71,"interventionNames":72},"Oliceridine group","EXPERIMENTAL","Administer a loading dose of 0.02 mg\u002Fkg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.4 mg\u002Fkg oliceridine diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL\u002Fh, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours. The cumulative oliceridine dose should not exceed 27 mg per 24 hours, in accordance with the FDA prescribing information.",[73],"Drug: Oliceridine",{"label":75,"type":76,"description":77,"interventionNames":78},"Sufentanil group","ACTIVE_COMPARATOR","Administer a loading dose of 0.1 μg\u002Fkg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 2 μg\u002Fkg sufentanil diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL\u002Fh, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours.",[79],"Drug: Sufentanil",[81,86],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":54},"DRUG","Oliceridine","postoperative patient-controlled analgesia (PCA)",[69],{"type":82,"name":87,"description":87,"armGroupLabels":88,"otherNames":54},"Sufentanil",[75],[90],{"name":91,"affiliation":5,"role":92},"Yang Jiao, Doctor","PRINCIPAL_INVESTIGATOR",[94,98],{"name":91,"role":95,"phone":96,"phoneExt":54,"email":97},"CONTACT","+86 159 0029 2506","jiaoxiuxiu1987@163.com",{"name":99,"role":95,"phone":54,"phoneExt":54,"email":100},"Yonghao Yu, Doctor","yuyonghaoemail@126.com",[102,119,131,143,152,161,170],{"facility":103,"status":104,"city":105,"state":106,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"The No. 2 Hospital of Baoding","RECRUITING","Baoding","Hebei","China","CN",{"type":110,"coordinates":111},"Point",[112,113],115.46246,38.87288,{"lat":113,"lon":112},[116],{"name":117,"role":95,"phone":118,"phoneExt":54,"email":54},"Tianfang Qu","+86 15933938242",{"facility":120,"status":104,"city":121,"state":106,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"North China University of Science and Technology Affiliated Hospital","Tangshan",{"type":110,"coordinates":123},[124,125],118.18319,39.64381,{"lat":125,"lon":124},[128],{"name":129,"role":95,"phone":130,"phoneExt":54,"email":54},"Shubo Zhang","+86 15383055768",{"facility":5,"status":104,"city":132,"state":54,"zip":133,"country":107,"countryCode":108,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Tianjin","300052",{"type":110,"coordinates":135},[136,137],117.17667,39.14222,{"lat":137,"lon":136},[140],{"name":141,"role":95,"phone":142,"phoneExt":54,"email":97},"Yang Jiao","+86 15900292506",{"facility":144,"status":104,"city":132,"state":54,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Haibin People's Hospital of Tianjin Binhai New Area",{"type":110,"coordinates":146},[136,137],{"lat":137,"lon":136},[149],{"name":150,"role":95,"phone":151,"phoneExt":54,"email":54},"Lifeng Lu","+86 18522593633",{"facility":153,"status":104,"city":132,"state":54,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"The People's Hospital of Jizhou District, Tianjin",{"type":110,"coordinates":155},[136,137],{"lat":137,"lon":136},[158],{"name":159,"role":95,"phone":160,"phoneExt":54,"email":54},"Hongying Mu","+86 18622657601",{"facility":162,"status":104,"city":132,"state":54,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"The Second Hospital of Tianjin Medical University",{"type":110,"coordinates":164},[136,137],{"lat":137,"lon":136},[167],{"name":168,"role":95,"phone":169,"phoneExt":54,"email":54},"Shuhui Xin","+86 15922074002",{"facility":171,"status":104,"city":132,"state":54,"zip":54,"country":107,"countryCode":108,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Tianjin Cancer Hospital Airport Hospital",{"type":110,"coordinates":173},[136,137],{"lat":137,"lon":136},[176],{"name":177,"role":95,"phone":178,"phoneExt":54,"email":54},"Yifu Tian","+86 18322473181",{"type":92,"investigatorFullName":141,"investigatorTitle":180,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Associate Chief Physician",[182,183,185,187,189,190],{"name":103,"class":6},{"name":171,"class":184},"UNKNOWN",{"name":186,"class":6},"Tianjin Medical University Second Hospital",{"name":188,"class":6},"North China University of Science and Technology",{"name":144,"class":184},{"name":153,"class":184},"100594356","phase-4-the-effect-of-oliceridine-patient-controlled-intravenous-analgesia-on-postoperative-chronic-pain-after-video-assisted-thoracoscopic-lobectomy-100594356",false,"NCT07018375","Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lung Resection","Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol","Inclusion Criteria:\n\n* Age 18-75 years\n* ASA physical status I-III\n* BMI 18-35 kg\u002Fm²\n* Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancerresection for lung cancer\n* Preoperative Numeric Rating Scale (NRS) pain score of 0\n* Ability to understand the study objectives and procedures, with voluntary informed consent obtained\n* Expected postoperative recovery in the general ward setting\n\nExclusion Criteria:\n\n* History of chronic pain or long-term analgesic use prior to surgery\n* Previous ipsilateral thoracic surgery\n* Prior neoadjuvant radiotherapy or chemotherapy\n* Severe cardiovascular or cerebrovascular disease, or hepatic\u002Frenal dysfunction (ALT\u002FAST \\> 3 × upper limit of normal; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²)\n* Severe or unstable psychiatric disorders requiring psychoactive medication (e.g., schizophrenia, bipolar disorder), or cognitive impairment precluding reliable self-report\n* Other concurrent active malignancy or active infection\n* Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics)\n* Pregnancy, lactation, or planned pregnancy during the study period\n* Participation in another interventional clinical trial within 3 months before enrolment\n* Any condition deemed unsuitable for study participation by the investigator","ALL","18 Years","75 Years",{"count":202,"type":203},320,"ESTIMATED","INTERVENTIONAL",[206],"PHASE4","The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery.",[209],"Chronic Postsurgical Pain",[211,212,213,214,215],"oliceridine","sufentanil","chronic postsurgical pain","VATS","patient-controlled analgesia","2026-08-28",{"date":218,"type":219},"2026-09-01","ACTUAL",{"date":221,"type":219},"2026-01-06",{"date":223,"type":203},"2027-04-30",{"name":5,"class":6},7]