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Clinical Trials/NCT03245294
NCT03245294CompletedNot Applicable

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

Keimyung University Dongsan Medical Center2 sites in 1 country104 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
104
Locations
2
Primary Endpoint
pattern of epidural pressure decrease

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • lumbar herniated nucleus
  • lumbar spinal stenosis
  • internal disc disruption
  • 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

Arms & Interventions

Lumbar ESI with paramedian approach

Active Comparator

Lumbar ESI with paramedian approach

Intervention: lumbar epidural injection (Procedure)

Lumbar ESI with midline approach

Active Comparator

Lumbar ESI with midline approach

Intervention: lumbar epidural injection (Procedure)

Outcomes

Primary Outcomes

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

  • factors contributing the epidural pressure pattern(60 minutes after the completion of entry from ligamentum flavum to epidural space)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

Study Sites (2)

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