The Use of Paravertebral Block for Cardiac Surgery
2016年2月16日 更新者:NYU Langone Health
Study of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage.
Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied.
Currently the investigators routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted).
The investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
研究概览
详细说明
Pain after robotic cardiac surgery is a known problem and is often difficult to manage.
Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied.
Currently we routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted).
We believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
研究类型
介入性
注册 (实际的)
60
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
-
-
New York
-
New York、New York、美国、10016
- NYU Langone Medical Center
-
-
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 至 90年 (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 over the age of 18 years of age undergoing robotic mitral valve surgery.
- have capacity to understand and sign consent form
Exclusion Criteria:
- patients that are not candidates for paravertebral block as per ASRA guidelines (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an INR of greater than 1.5. -patients with a history of COPD or other respiratory diseases that would confound data on time to extubated will be excluded.
- Patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.
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:治疗
- 分配:随机化
- 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:Paravertebral block
Patient receiving a PVB prior to robotic mitral valve surgery
|
Paravertebral nerve block injection
|
|
安慰剂比较:No block
Patients who did not receive PVB
|
No block Patients who did not receive PVB |
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 |
|---|---|---|
|
Postoperative Fentanyl
大体时间:24 hours
|
24 hours
|
|
|
Visual Analog Scale (VAS) Pain Scores
大体时间:24 hours
|
Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain
|
24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant Satisfaction
大体时间:48 hours
|
Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)
|
48 hours
|
|
Participant Satisfaction Score
大体时间:48 hours
|
Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)
|
48 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:Peter J Neuburger, MD、NYU
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Suri RM, Antiel RM, Burkhart HM, Huebner M, Li Z, Eton DT, Topilsky T, Sarano ME, Schaff HV. Quality of life after early mitral valve repair using conventional and robotic approaches. Ann Thorac Surg. 2012 Mar;93(3):761-9. doi: 10.1016/j.athoracsur.2011.11.062.
- Lynch JJ, Mauermann WJ, Pulido JN, Rehfeldt KH, Torres NE. Use of paravertebral blockade to facilitate early extubation after minimally invasive cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Mar;14(1):47-8. doi: 10.1177/1089253210363009.
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
2013年1月1日
初级完成 (实际的)
2014年4月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2014年7月1日
首先提交符合 QC 标准的
2014年7月2日
首次发布 (估计)
2014年7月3日
研究记录更新
最后更新发布 (估计)
2016年3月15日
上次提交的符合 QC 标准的更新
2016年2月16日
最后验证
2016年2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.