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布比卡因脂质体注射液用于小儿局部镇痛的研究

2026年9月23日 更新者：Jiangsu HengRui Medicine Co., Ltd.

布比卡因脂质体注射液局部浸润治疗小儿骨科手术后急性术后疼痛的真实世界研究

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

232

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • 招聘中
        • Guangzhou Women and Children's Medical Center
        • 接触：
        • 首席研究员：
          • Xingrong Song

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subjects and guardians are willing to sign the informed consent.
  2. Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length ≥ 3cm.
  3. 6 years old ≤ age ≤ 17 years old, Male or female.
  4. ASA Physical Status Classification I-III.

Exclusion Criteria:

  1. Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.
  2. Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days.
  3. Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate.
  4. Subjects with a history of chronic pain or visceral pain.
  5. Subjects with abnormal liver and kidney function.
  6. Subjects with clinically significant abnormal heart rate or rhythm.
  7. Subjects who are participating or planning to participate in any interventional clinical trial.
  8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：布比卡因脂质体注射液
药品：Bupivacaine Liposome Injection

Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
大体时间：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).
0 minute to 14 days after administration

次要结果测量

结果测量
措施说明
大体时间
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
大体时间：0 minute to 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
Time to first rescue analgesia of opioid
大体时间：0 minute to 72 hours after administration

Duration from administration to first use of opioid for rescue analgesia.
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
大体时间：0 minute to 72 hours after administration

The proportion of patients who did not use rescue analgesia during 72 hours after administration.
0 minute to 72 hours after administration
The proportion of patients using patient-controlled intravenous analgesia (PCIA)
大体时间：0 minute to 72 hours after administration

The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 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
大体时间：0 minute to 72 hours after administration

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).
0 minute to 72 hours after administration
Pain intensity score at rest after administration for children aged 8 years and older
大体时间：0 minute to 72 hours after administration

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).
0 minute to 72 hours after administration
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
大体时间：0 minute to 72 hours after administration

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).
0 minute to 72 hours after administration
Pain intensity score on movement (or cough) after administration for children aged 8 years and older
大体时间：0 minute to 72 hours after administration

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).
0 minute to 72 hours after administration
Length of Stay
大体时间：Up to 2 weeks

The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.
Up to 2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jiangsu HengRui Medicine Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月21日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2024年3月13日

首先提交符合 QC 标准的

2024年3月27日

首次发布 (实际的)

2024年4月3日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • ZYWB-ZM-AHP-A-003

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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