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Factors Contributing to the Pressure Wave Form Changes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03245294
Enrollment
104
Registered
2017-08-10
Start date
2017-08-01
Completion date
2018-04-11
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analysis, Event History

Keywords

cervical epidural space, abrupt pressure decrease

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.

Interventions

the pattern of pressure decrease from ligamentum flavum to epidural space

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pattern of epidural pressure decrease1 second after the completion of entry from ligamentum flavum to epidural spaceabrupt or gradual decrease of epidural pressure

Secondary

MeasureTime frameDescription
factors contributing the epidural pressure pattern60 minutes after the completion of entry from ligamentum flavum to epidural spacefactors contributing the epidural pressure decrease(abrupt vs. gradual) pattern

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026