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Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02838654
Enrollment
75
Registered
2016-07-20
Start date
2016-07-31
Completion date
2017-06-30
Last updated
2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analysis, Event History

Keywords

cervical epidural space, wave form analysis

Brief summary

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

Detailed description

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.

Interventions

sensitivity, specificity, positive predictive value, negative predictive value

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Coagulopathy * Infectious cervical disease * Pregnancy

Design outcomes

Primary

MeasureTime frame
epidural wave form reliability (sensitivity, specificity) analysis1 minute after the completion of the epidural injection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026