Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

November 28, 2017 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who complain chronic neck pain due to cervical spinal disease or acute herpes zoster

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Coagulopathy
  • Infectious cervical disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cervical epidural injection group
Procedure: cervical epidural injection
sensitivity, specificity, positive predictive value, negative predictive value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
epidural wave form reliability (sensitivity, specificity) analysis
Time Frame: 1 minute after the completion of the epidural injection
1 minute after the completion of the epidural injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Investigators

  • Principal Investigator: JiHEE Hong, MD, PhD, Keimyung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 17, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-05-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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