Factors Contributing to the Pressure Wave Form Changes

Keimyung University

Status: Completed

Conditions: Analysis, Event History

Treatments: Procedure: lumbar epidural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03245294

2017-05-039

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Lumbar ESI with paramedian approach

Active Comparator group

Description:

Lumbar ESI with paramedian approach

Treatment:

Procedure: lumbar epidural injection

Lumbar ESI with midline approach

Active Comparator group

Description:

Lumbar ESI with midline approach

Treatment:

Procedure: lumbar epidural injection