Clinical Trials Directory

Trials / Completed

CompletedNCT03245294

Factors Contributing to the Pressure Wave Form Changes

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Keimyung University Dongsan Medical Center · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElumbar epidural injectionthe pattern of pressure decrease from ligamentum flavum to epidural space

Timeline

Start date
2017-08-01
Primary completion
2018-04-11
Completion
2018-04-11
First posted
2017-08-10
Last updated
2018-04-17

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03245294. Inclusion in this directory is not an endorsement.