NCT06344091招募中4 期
A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length ≥ 3cm.
- 6 years old ≤ age ≤ 17 years old, Male or female.
- ASA Physical Status Classification I-III.
排除标准
- Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.
- Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days.
- Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate.
- Subjects with a history of chronic pain or visceral pain.
- Subjects with abnormal liver and kidney function.
- Subjects with clinically significant abnormal heart rate or rhythm.
- Subjects who are participating or planning to participate in any interventional clinical trial.
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Bupivacaine Liposome Injection
Experimental
干预措施: Bupivacaine Liposome Injection (Drug)
结局指标
主要结局
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
时间窗: 0 minute to 14 days after administration
Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities).
次要结局
- Pain intensity score at rest after administration for children aged 8 years and older(0 minute to 72 hours after administration)
- Pain intensity score on movement (or cough) after administration for children aged 8 years and older(0 minute to 72 hours after administration)
- Length of Stay(Up to 2 weeks)
- Time to first rescue analgesia of opioid(0 minute to 72 hours after administration)
- 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(0 minute to 72 hours after administration)
- Pain intensity score at rest after administration for children aged 6 to 7 years(0 minute to 72 hours after administration)
- Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years(0 minute to 72 hours after administration)
- The proportion of patients using patient-controlled intravenous analgesia (PCIA)(0 minute to 72 hours after administration)
- The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration(0 minute to 72 hours after administration)
- Length of Stay(up to 2 weeks)
研究者
研究点 (2)
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标识符
- NCT 编号
- NCT06344091
- 其他研究编号
- ZYWB-ZM-AHP-A-003
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (7个月后)
- 研究完成日期
- (7个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
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