Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- pattern of epidural pressure decrease
研究概览
简要总结
The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lumbar herniated nucleus
- •lumbar spinal stenosis
- •internal disc disruption
- •ODI > 20
排除标准
- •coagulopathy
- •allergy to contrast media
- •infection at needle insertion site
- •absence of lumbar MRI
- •Pregnancy
- •previous lumbar spine surgery
- •neurological symptoms requiring prompt reevalution
研究组 & 干预措施
Lumbar ESI with paramedian approach
Lumbar ESI with paramedian approach
干预措施: lumbar epidural injection (Procedure)
Lumbar ESI with midline approach
Lumbar ESI with midline approach
干预措施: lumbar epidural injection (Procedure)
结局指标
主要结局
pattern of epidural pressure decrease
时间窗: 1 second after the completion of entry from ligamentum flavum to epidural space
abrupt or gradual decrease of epidural pressure
次要结局
- factors contributing the epidural pressure pattern(60 minutes after the completion of entry from ligamentum flavum to epidural space)
研究者
Ji Hee Hong
Professor
Keimyung University Dongsan Medical Center
