Factors Contributing to the Pressure Wave Form Changes

Study Overview
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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.

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.

Official Title
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Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections

Conditions
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Analysis, Event History

Intervention / Treatment
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* Procedure: lumbar epidural injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar ESI with paramedian approach<br>Lumbar ESI with paramedian approach | Procedure: lumbar epidural injection<br>* the pattern of pressure decrease from ligamentum flavum to epidural space<br>|
| Active Comparator: Lumbar ESI with midline approach<br>Lumbar ESI with midline approach | Procedure: lumbar epidural injection<br>* the pattern of pressure decrease from ligamentum flavum to epidural space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pattern of epidural pressure decrease | abrupt or gradual decrease of epidural pressure | 1 second after the completion of entry from ligamentum flavum to epidural space | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors contributing the epidural pressure pattern | factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern | 60 minutes after the completion of entry from ligamentum flavum to epidural space | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical epidural space, abrupt pressure decrease