Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California, San Francisco
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Robotic or Video-Assisted Lung Resection for All Indications
Exclusion Criteria:
- Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
- Extra-Thoracic Procedures
- Hypersensitivity to Amide Local Analgesia
- Cardiac Conduction Abnormalities
- Hepatic Dysfunction
- Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Liposomal Bupivacaine
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc. |
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
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有源比较器：Standard Bupivacaine
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc. |
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
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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 |
|---|---|---|
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Average Daily In-Hospital Use of Opioids
大体时间：Average over Entire Length of Hospitalization (Up to 1 Week)
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Measured in Oral Morphine Equivalents per Day
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Average over Entire Length of Hospitalization (Up to 1 Week)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average Daily In-Hospital Pain Score
大体时间：Average over Length of Hospitalization - Up to 1 Week
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Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).
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Average over Length of Hospitalization - Up to 1 Week
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Number of Participants With Postoperative Pneumonia
大体时间：Index Hospitalization following Surgery until Discharge - Up to 1 Week
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Pneumonia (Y/N)
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Index Hospitalization following Surgery until Discharge - Up to 1 Week
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Length of Stay
大体时间：Index Hospitalization following Surgery until Discharge - Up to 1 Week
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Measured in Days
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Index Hospitalization following Surgery until Discharge - Up to 1 Week
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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