Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
2020年1月22日 更新者：Virginia Commonwealth University
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.
研究概览
地位
撤销
详细说明
The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery.
This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery.
As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection.
Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids.
The study will use a continuous reassessment model to determine the optimal dose.
研究类型
介入性
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。
学习地点
-
-
Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University
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-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively
Exclusion Criteria:
- BMI >40
- infection at the proposed catheter site
- ongoing sepsis/bacteremia
- patient unable to sit up for the procedure
- patients requiring significant vasopressor support (>1 vasopressor)
- patient refusal
- less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)
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：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Bilateral catheters
patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
|
Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
|
|
实验性的：Single catheter
patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
|
Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.
|
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 |
|---|---|---|
|
Median Effective Dose
大体时间：6.5 hours
|
Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)
|
6.5 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pain rating
大体时间：From just before to 30 minutes after a bolus is administered
|
Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be
|
From just before to 30 minutes after a bolus is administered
|
|
Change in heart rate
大体时间：From just before to 30 minutes after a bolus is administered
|
Heart rate measured using a heart rate monitor
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From just before to 30 minutes after a bolus is administered
|
|
Blood pressure
大体时间：From just before to 30 minutes after a bolus is administered
|
Blood pressure measured using a blood pressure monitor
|
From just before to 30 minutes after a bolus is administered
|
|
Change in percent oxygen saturation of hemoglobin
大体时间：From just before to 30 minutes after a bolus is administered
|
Pulse oximetry reading from a monitor
|
From just before to 30 minutes after a bolus is administered
|
|
Changes in electrocardiogram tracing
大体时间：From just before a bolus is administered to 6.5 hours
|
Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.
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From just before a bolus is administered to 6.5 hours
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Dermatomal coverage
大体时间：From just before to 30 minutes after a bolus is administered
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The area of numbness experienced in the chest wall as measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
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From just before to 30 minutes after a bolus is administered
|
|
Opioid consumption
大体时间：6.5 hours
|
Total opioid medication consumption during the study period
|
6.5 hours
|
|
Non-narcotic pain medication consumption
大体时间：6.5 hours
|
Total non-narcotic pain medicine consumption during the study period
|
6.5 hours
|
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。
调查人员
- 首席研究员：Bryant Tran, MD、Virginia Commonwealth University
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)
2019年7月23日
初级完成 (预期的)
2020年9月1日
研究完成 (预期的)
2020年9月1日
研究注册日期
首次提交
2019年5月21日
首先提交符合 QC 标准的
2019年5月21日
首次发布 (实际的)
2019年5月23日
研究记录更新
最后更新发布 (实际的)
2020年1月27日
上次提交的符合 QC 标准的更新
2020年1月22日
最后验证
2020年1月1日
更多信息
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.