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Completed

NCT Number: NCT03245294

Factors Contributing to the Pressure Wave Form Changes

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ji Hee Hong

Daegu, 700712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar epidural injection

Procedure

the pattern of pressure decrease from ligamentum flavum to epidural space

Primary outcomes

  1. pattern of epidural pressure decrease

    Time frame: 1 second after the completion of entry from ligamentum flavum to epidural space

    abrupt or gradual decrease of epidural pressure

Secondary outcomes

  1. factors contributing the epidural pressure pattern

    Time frame: 60 minutes after the completion of entry from ligamentum flavum to epidural space

    factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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