[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542532":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":49,"interventions":55,"overallOfficials":41,"centralContacts":60,"locations":66,"responsibleParty":87,"collaborators":41,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":41,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":41,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":41,"overallStatus":69,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system","Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities).","0 minute to 14 days after administration",[14,18,21,24,27,30,33,35,37],{"measure":15,"description":16,"timeFrame":17},"The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration","Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration.","0 minute to 72 hours after administration",{"measure":19,"description":20,"timeFrame":17},"Time to first rescue analgesia of opioid","Duration from administration to first use of opioid for rescue analgesia.",{"measure":22,"description":23,"timeFrame":17},"The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration","The proportion of patients who did not use rescue analgesia during 72 hours after administration.",{"measure":25,"description":26,"timeFrame":17},"The proportion of patients using patient-controlled intravenous analgesia (PCIA)","The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration.",{"measure":28,"description":29,"timeFrame":17},"Pain intensity score at rest after administration for children aged 6 to 7 years","Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).",{"measure":31,"description":32,"timeFrame":17},"Pain intensity score at rest after administration for children aged 8 years and older","Numerical Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).",{"measure":34,"description":29,"timeFrame":17},"Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years",{"measure":36,"description":32,"timeFrame":17},"Pain intensity score on movement (or cough) after administration for children aged 8 years and older",{"measure":38,"description":39,"timeFrame":40},"Length of Stay","The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.","Up to 2 weeks",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"NA","SINGLE_GROUP","A single-arm study of liposomal bupivacaine injection","PREVENTION",{"masking":48,"maskingDescription":41,"whoMasked":41},"NONE",[50],{"label":51,"type":52,"description":41,"interventionNames":53},"Bupivacaine Liposome Injection","EXPERIMENTAL",[54],"Drug: Bupivacaine Liposome Injection",[56],{"type":57,"name":51,"description":58,"armGroupLabels":59,"otherNames":41},"DRUG","Bupivacaine Liposome Injection 4 mg\u002Fkg (up to a maximum of 266 mg)",[51],[61],{"name":62,"role":63,"phone":64,"phoneExt":41,"email":65},"Thea Yu","CONTACT","+86-0518-82342973","suyang.yu.sy17@hengrui.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Guangzhou Women and Children's Medical Center","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":76,"coordinates":77},"Point",[78,79],113.25,23.11667,{"lat":79,"lon":78},[82,85],{"name":83,"role":63,"phone":41,"phoneExt":41,"email":84},"Xingrong Song","sxjess@126.com",{"name":83,"role":86,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100542532","phase-4-a-study-of-bupivacaine-liposome-injection-in-local-analgesia-of-pediatric-patients-100542532",false,"NCT06344091","A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients","A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery","Inclusion Criteria:\n\n1. Subjects and guardians are willing to sign the informed consent.\n2. Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length ≥ 3cm.\n3. 6 years old ≤ age ≤ 17 years old, Male or female.\n4. ASA Physical Status Classification I-III.\n\nExclusion Criteria:\n\n1. Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.\n2. Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days.\n3. Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate.\n4. Subjects with a history of chronic pain or visceral pain.\n5. Subjects with abnormal liver and kidney function.\n6. Subjects with clinically significant abnormal heart rate or rhythm.\n7. Subjects who are participating or planning to participate in any interventional clinical trial.\n8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.","ALL","6 Years","17 Years",{"count":100,"type":101},232,"ESTIMATED","INTERVENTIONAL",[104],"PHASE4","The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.",[107],"Local Analgesia Via Infiltration","2026-09-23",{"date":110,"type":111},"2026-09-28","ACTUAL",{"date":113,"type":111},"2024-05-21",{"date":115,"type":101},"2027-05",{"name":5,"class":6},1]