Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

Analysis, Event History Clinical Trial

Official title:

Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838654
• Other study ID #: 2016-05-037
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: November 28, 2017
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cerivical Herniated nucleusus

• Cerivical spinal stenosis

• acute herpes zoster

Exclusion Criteria:

• Coagulopathy

• Infectious cervical disease

• Pregnancy

Related Conditions & MeSH terms

• Analysis, Event History

Intervention

Procedure:
• cervical epidural injection
sensitivity, specificity, positive predictive value, negative predictive value

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidural wave form reliability (sensitivity, specificity) analysis		1 minute after the completion of the epidural injection