Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
2010年9月23日 更新者：University of California, San Diego
The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.
研究概览
详细说明
To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.
Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.
研究类型
介入性
注册 (预期的)
50
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
-
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California
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San Diego、California、美国、92103
- UCSD Medical Center
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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:
- primary, unilateral hip arthroplasty or hip resurfacing
- age greater than or equal to 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion
Exclusion Criteria:
- morbid obesity (BMI greater than 40)
- chronic, high-dose opioid use
- history of opioid abuse
- pregnancy
- incarceration
- amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
- inability to communicate with hospital staff
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1. Femoral Nerve Block
Patients will be randomized with a computer program to receive a femoral catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
|
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
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有源比较器：2. Psoas Compartment Catheter
Patients will be randomized with a computer program to receive a psoas compartment catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
|
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.
大体时间：24 hours beginning 7:30am day following surgery
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24 hours beginning 7:30am day following surgery
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Analgesic used, as reported by nursing staff in the UCSD computer system.
大体时间：3 days following surgery
|
3 days following surgery
|
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Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.
大体时间：3 days following surgery
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3 days following surgery
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Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.
大体时间：3 days following surgery
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3 days following surgery
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Infusion duration of pain pump, measured on the pump itself in hours and minutes.
大体时间：3 days following surgery
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3 days following surgery
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Duration of hospital stay, in hours, as reported in the UCSD computer system.
大体时间：3 days following surgery
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3 days following surgery
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Surgical/anesthetic adverse events as reported by hospital staff
大体时间：day of surgery and 3 days following
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day of surgery and 3 days following
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Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.
大体时间：1 week following surgery
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1 week following surgery
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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。
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。
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
2009年9月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2010年8月1日
研究注册日期
首次提交
2009年8月27日
首先提交符合 QC 标准的
2009年8月27日
首次发布 (估计)
2009年8月28日
研究记录更新
最后更新发布 (估计)
2010年9月24日
上次提交的符合 QC 标准的更新
2010年9月23日
最后验证
2010年9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.