Factors Contributing to the Pressure Wave Form Changes
Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
研究概览
详细说明
Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is felt through the sudden decrease of pressure and this pressure gradient is generated when the needle is within the passage of interspinous ligament, ligamentum flavum and epidural space. The presence of ligamentum flavum is crucial for the identification of epidural space by LOR. However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament can modify this passage and a false LOR is generated consequentially. The false positive rate of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the false positive rate is high, repeated attempts of epidural steroid injection (ESI) are required, with additional discomfort or pain to the patient.
The high rate of false LOR has prompted the design of adjunctive modalities. Among these, epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile wave coinciding with arterial pulsations can be seen through the monitor.
Recent study suggested that significant abrupt pressure decrease occurs when cervical epidural injection was done via paramedian approach rather than midline.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Daegu、大韩民国、700712
- Ji Hee Hong
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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:
- lumbar herniated nucleus
- lumbar spinal stenosis
- internal disc disruption
- NRS > 5
- ODI > 20
Exclusion Criteria:
- coagulopathy
- allergy to contrast media
- infection at needle insertion site
- absence of lumbar MRI
- Pregnancy
- previous lumbar spine surgery
- neurological symptoms requiring prompt reevalution
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：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 |
|---|---|
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有源比较器：Lumbar ESI with paramedian approach
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the pattern of pressure decrease from ligamentum flavum to epidural space
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有源比较器：Lumbar ESI with midline approach
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the pattern of pressure decrease from ligamentum flavum to epidural space
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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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pattern of epidural pressure decrease
大体时间：1 second after the completion of entry from ligamentum flavum to epidural space
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abrupt or gradual decrease of epidural pressure
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1 second after the completion of entry from ligamentum flavum to epidural space
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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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factors contributing the epidural pressure pattern
大体时间：60 minutes after the completion of entry from ligamentum flavum to epidural space
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factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern
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60 minutes after the completion of entry from ligamentum flavum to epidural space
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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
与本研究相关的术语
其他研究编号
- 2017-05-039
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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lumbar epidural injection的临床试验
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University of AlbertaCurtin University; American Orthotic and Prosthetic Association招聘中
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Xiamen Amoytop Biotech Co., Ltd.尚未招聘