Clinical trial NCT03245294: Factors Contributing to the Pressure Wave Form Changes
Official title: Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analysis, Event History
Keywords: cervical epidural space
abrupt pressure decrease
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: pattern of epidural pressure decrease
timeFrame: 1 second after the completion of entry from ligamentum flavum to epidural space
Secondary outcomes:
measure: factors contributing the epidural pressure pattern
timeFrame: 60 minutes after the completion of entry from ligamentum flavum to epidural space
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hee Hong
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References: