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Completed

NCT Number: NCT02838654

Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

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Key information

Conditions

Analysis, Event History

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.

Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.

Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerivical Herniated nucleusus
  • Cerivical spinal stenosis
  • acute herpes zoster

Exclusion criteria

  • Coagulopathy
  • Infectious cervical disease
  • Pregnancy

Treatment and study plan

Cervical Epidural Injection

Procedure

sensitivity, specificity, positive predictive value, negative predictive value

Primary outcomes

  1. epidural wave form reliability (sensitivity, specificity) analysis

    Time frame: 1 minute after the completion of the epidural injection

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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