Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT03245294
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Contributing to the Pressure Wave Form Changes
Sponsor:
Keimyung University Dongsan Medical Center
Organization:
Study Overview
Official Title:
Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: