Clinical Trials Directory

Trials / Completed

CompletedNCT02838654

Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

Status
Completed
Phase
Study type
Observational
Enrollment
75 (actual)
Sponsor
Keimyung University Dongsan Medical Center · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcervical epidural injectionsensitivity, specificity, positive predictive value, negative predictive value

Timeline

Start date
2016-07-01
Primary completion
2017-05-01
Completion
2017-06-01
First posted
2016-07-20
Last updated
2017-11-30

Source: ClinicalTrials.gov record NCT02838654. Inclusion in this directory is not an endorsement.