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临床试验/NCT03245294
NCT03245294已完成不适用

Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

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

Active Comparator

Lumbar ESI with paramedian approach

干预措施: lumbar epidural injection (Procedure)

Lumbar ESI with midline approach

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

研究点 (1)

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