Factors Contributing to the Pressure Wave Form Changes

Not Applicable

Completed

• Conditions: Analysis, Event History
• Interventions: Procedure: lumbar epidural injection

• Registration Number: NCT03245294
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Status Verified: 2018-04
• Primary Completion: 2018-04-11
• Study Completion: 2018-04-11
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar ESI with midline approach	lumbar epidural injection	Lumbar ESI with midline approach
Lumbar ESI with paramedian approach	lumbar epidural injection	Lumbar ESI with paramedian approach

Primary Outcome Measures

Name	Time	Method
pattern of epidural pressure decrease	1 second after the completion of entry from ligamentum flavum to epidural space	abrupt or gradual decrease of epidural pressure

Secondary Outcome Measures

Name	Time	Method
factors contributing the epidural pressure pattern	60 minutes after the completion of entry from ligamentum flavum to epidural space	factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern

Trial Locations

Locations (1)

Ji Hee Hong; 🇰🇷 Daegu, Korea, Republic of