[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610585":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":47,"responsibleParty":135,"collaborators":30,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":30,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":30,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":164,"whyStopped":30,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Tegileridine 20 μg\u002Fkg Loading Dose + 1 μg\u002Fkg PCA","EXPERIMENTAL","Participants in this arm will receive an initial intravenous loading dose of 20 μg\u002Fkg Tegileridine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting Tegileridine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 1 μg\u002Fkg Tegileridine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation.",[13],"Drug: Tegileridine",{"label":15,"type":10,"description":16,"interventionNames":17},"Tegileridine 20 μg\u002Fkg Loading Dose + 2 μg\u002Fkg PCA","Participants in this arm will receive an initial intravenous loading dose of 20 μg\u002Fkg Tegileridine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting Tegileridine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 2 μg\u002Fkg Tegileridine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Morphine 60 μg\u002Fkg Loading Dose + 20 μg\u002Fkg PCA","ACTIVE_COMPARATOR","Participants in this arm will receive an initial intravenous loading dose of 60 μg\u002Fkg morphine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting morphine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 20 μg\u002Fkg morphine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation.",[23],"Drug: morphine",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Tegileridine","Tegileridine is a novel μ-opioid receptor-biased agonist. In this study, it is administered as an initial intravenous loading dose immediately followed by patient-controlled analgesia (PCA) for postoperative pain management. The PCA solution is prepared by diluting the Tegileridine injection in normal saline.",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"morphine","Morphine is a standard opioid analgesic used as the active comparator in this study. It is administered as an initial intravenous loading dose immediately followed by patient-controlled analgesia (PCA) for postoperative pain management. The PCA solution is prepared by diluting Morphine injection in normal saline.",[19],[36],{"name":37,"affiliation":5,"role":38},"Ling Lan, Doctor","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Juelun Wu, Doctor","CONTACT","+86 18707486338","pumchwujuelun@163.com",{"name":37,"role":42,"phone":46,"phoneExt":30,"email":30},"+86 18612672275",[48,67,83,98,106,122],{"facility":49,"status":30,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Henan Provincial People's Hospital","Zhengzhou","Henan","450003","China","CN",{"type":56,"coordinates":57},"Point",[58,59],113.64861,34.75778,{"lat":59,"lon":58},[62,66],{"name":63,"role":42,"phone":64,"phoneExt":30,"email":65},"Mingzhu Cui, Doctor","+86 18639006993","Cuimingzhu78@163.com",{"name":63,"role":38,"phone":30,"phoneExt":30,"email":30},{"facility":68,"status":30,"city":69,"state":70,"zip":71,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":56,"coordinates":73},[74,75],115.85306,28.68396,{"lat":75,"lon":74},[78,82],{"name":79,"role":42,"phone":80,"phoneExt":30,"email":81},"Xiaoping Zhu, Doctor","+ 86 13907915506","13907915506@163.com",{"name":79,"role":38,"phone":30,"phoneExt":30,"email":30},{"facility":84,"status":30,"city":85,"state":30,"zip":86,"country":53,"countryCode":54,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Beijing Chao-yang Hospital, Capital Medical University","Beijing","100020",{"type":56,"coordinates":88},[89,90],116.39723,39.9075,{"lat":90,"lon":89},[93,97],{"name":94,"role":42,"phone":95,"phoneExt":30,"email":96},"Changwei Wei, Doctor","+86 13810678936","changwei.wei@ccmu.edu.cn",{"name":94,"role":38,"phone":30,"phoneExt":30,"email":30},{"facility":5,"status":30,"city":85,"state":30,"zip":99,"country":53,"countryCode":54,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"100730",{"type":56,"coordinates":101},[89,90],{"lat":90,"lon":89},[104,105],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},{"name":37,"role":38,"phone":30,"phoneExt":30,"email":30},{"facility":107,"status":30,"city":108,"state":30,"zip":109,"country":53,"countryCode":54,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","Shanghai","200092",{"type":56,"coordinates":111},[112,113],121.45806,31.22222,{"lat":113,"lon":112},[116,120],{"name":117,"role":42,"phone":118,"phoneExt":30,"email":119},"Yi Du, Doctor","+86 18101896668","duyi01@xinhuamed.com.cn",{"name":121,"role":38,"phone":30,"phoneExt":30,"email":30},"Lai Jiang, Doctor",{"facility":123,"status":30,"city":108,"state":30,"zip":124,"country":53,"countryCode":54,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University","200127",{"type":56,"coordinates":126},[112,113],{"lat":113,"lon":112},[129,133],{"name":130,"role":42,"phone":131,"phoneExt":30,"email":132},"Hualin Chen, Doctor","+86 18930329981","18930329981@163.com",{"name":134,"role":38,"phone":30,"phoneExt":30,"email":30},"Jijian Zheng, Doctor",{"type":38,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Lan Ling","Principal Investigator","100610585","phase-4-tegileridine-for-postoperative-pain-after-adolescent-scoliosis-surgery-100610585",false,"NCT07229495","Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery","Efficacy and Safety of Tegileridine for Postoperative Analgesia Following Adolescent Scoliosis Correction Surgery: A Prospective, Multicentre, Double-Blind, Non-Inferiority, Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 10 years to less than 18 years.\n* Scheduled to undergo posterior spinal fusion (PSF) surgery for scoliosis under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status classification I to III.\n* The participant and their parent or legal guardian voluntarily provide written informed consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n* History of difficult airway, severe respiratory depression (SpO₂ \\\u003C 90%), acute or severe bronchial asthma.\n* History of severe cardiovascular or cerebrovascular disease, such as myocardial infarction, unstable angina, second-degree or higher atrioventricular block, NYHA Class III or higher heart failure, or stroke.\n* Known or suspected gastrointestinal obstruction, including paralytic ileus.\n* Known hypersensitivity to opioids or any component of the study drug formulation.\n* History of psychiatric disorders (e.g., schizophrenia, depression) or cognitive impairment.\n* Diagnosis of neuromuscular scoliosis or presence of any other chronic pain condition that may interfere with postoperative pain assessment.\n* Chronic use of opioid analgesics or use of any analgesic medication within 48 hours prior to surgery.\n* Planned postoperative admission to the intensive care unit (ICU).\n* Any other condition deemed by the investigator to be inappropriate for participation in the study.","ALL","10 Years","17 Years",{"count":149,"type":150},171,"ESTIMATED","INTERVENTIONAL",[153],"PHASE4","The goal of this clinical trial is to see if a new pain medicine called Tegileridine is at least as effective as morphine (the standard treatment) for pain relief after spinal surgery in teenagers with scoliosis. This type of study is called a \"non-inferiority\" trial. The study will also carefully compare the safety of both medicines.\n\nThe main questions it aims to answer are:\n\nIs Tegileridine no worse than morphine at controlling pain in the first 24 hours after surgery? How do the side effects (like sleepiness or nausea) of Tegileridine compare to those of morphine? Researchers will compare two different doses of Tegileridine against morphine. Neither the participants nor the doctors assessing them will know which medicine is being given.\n\nParticipants in this study will:\n\nReceive one of the three pain medicine options through a pump (called a PCA pump) that they can control themselves after surgery.\n\nUse the pump for up to 48 hours. Regularly rate their pain levels using a simple number scale. Have their health closely monitored by the study team during this time.",[156,157,158],"Scoliosis; Adolescence","Pain After Surgery","Analgesia, Patient-controlled",[27,160,161,162,163],"Postoperative Pain","Adolescent","Patient-Controlled Analgesia","Scoliosis","NOT_YET_RECRUITING","2026-06-15",{"date":167,"type":168},"2026-06-17","ACTUAL",{"date":170,"type":150},"2026-07-01",{"date":172,"type":150},"2027-09-30",{"name":5,"class":6},6]