The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
2014年6月10日 更新者：Loma Linda University
Dexamethasone is a commonly used steroid.
This medication has been used for many years by physicians for many different indications.
Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks.
This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics.
Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block.
Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.
研究概览
研究类型
介入性
注册 (实际的)
43
阶段
- 不适用
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
-
-
California
-
Loma Linda、California、美国、92354
- Loma Linda University 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 80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:
- Age 18-80 yrs, male or female subjects.
- Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
- American Society of Anesthesiology Class 1,2,3,or 4.
- Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
- Weight > or equal to 60kg.
Exclusion Criteria:
- Any allergies or hypersensitivity to ropivacaine or dexamethasone.
- Subject is on chronic steroids preoperatively for any reason.
- History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
- History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
- Contraindication to placement of sciatic nerve block.
- Sciatic block placement failure.
- Subject mistakenly receives steroids intraoperatively.
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：阶乘赋值
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Group A
This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
|
20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
2ml of normal saline given once intravenously.
|
|
实验性的：Group B
Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
|
20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
2ml of normal saline given once intravenously.
8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
2ml(8mg)Dexamethasone given once intravenously.
|
|
有源比较器：Group C
Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
|
20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
2ml(8mg)Dexamethasone given once intravenously.
|
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 |
|---|---|---|
|
Duration of Sciatic Nerve Block
大体时间：from the time the block was placed up to 24 hours
|
Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores
|
from the time the block was placed up to 24 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：Charles Lee, MD、Loma Linda 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
2007年8月1日
初级完成 (实际的)
2011年1月1日
研究完成 (实际的)
2011年5月1日
研究注册日期
首次提交
2008年2月4日
首先提交符合 QC 标准的
2008年2月4日
首次发布 (估计)
2008年2月15日
研究记录更新
最后更新发布 (估计)
2014年6月11日
上次提交的符合 QC 标准的更新
2014年6月10日
最后验证
2014年6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.