Factors Contributing to the Pressure Wave Form Changes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-04-11

Brief Summary

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The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.

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Detailed Description

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Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is felt through the sudden decrease of pressure and this pressure gradient is generated when the needle is within the passage of interspinous ligament, ligamentum flavum and epidural space. The presence of ligamentum flavum is crucial for the identification of epidural space by LOR. However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament can modify this passage and a false LOR is generated consequentially. The false positive rate of the lumbar and cervical area was reported to be 8.3\~17% and 30\~68%, respectively. If the false positive rate is high, repeated attempts of epidural steroid injection (ESI) are required, with additional discomfort or pain to the patient.

The high rate of false LOR has prompted the design of adjunctive modalities. Among these, epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile wave coinciding with arterial pulsations can be seen through the monitor.

Recent study suggested that significant abrupt pressure decrease occurs when cervical epidural injection was done via paramedian approach rather than midline.

Conditions

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Analysis, Event History

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Lumbar ESI with paramedian approach

Group Type ACTIVE_COMPARATOR

lumbar epidural injection

Intervention Type PROCEDURE

the pattern of pressure decrease from ligamentum flavum to epidural space

Lumbar ESI with midline approach

Group Type ACTIVE_COMPARATOR

lumbar epidural injection

Intervention Type PROCEDURE

the pattern of pressure decrease from ligamentum flavum to epidural space

Interventions

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lumbar epidural injection

the pattern of pressure decrease from ligamentum flavum to epidural space

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* lumbar herniated nucleus
* lumbar spinal stenosis
* internal disc disruption
* NRS \> 5
* ODI \> 20

Exclusion Criteria

* coagulopathy
* allergy to contrast media
* infection at needle insertion site
* absence of lumbar MRI
* Pregnancy
* previous lumbar spine surgery
* neurological symptoms requiring prompt reevalution

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No