Factors Contributing to the Pressure Wave Form Changes

Analysis, Event History Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245294
• Other study ID #: 2017-05-039
• Status: Completed
• Phase: N/A
• First received: August 3, 2017
• Last updated: April 13, 2018
• Start date: August 1, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: April 2018
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analysis, Event History

Intervention

Procedure:
• lumbar epidural injection
the pattern of pressure decrease from ligamentum flavum to epidural space

Locations

Country	Name	City	State
Korea, Republic of	Ji Hee Hong	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pattern of epidural pressure decrease	abrupt or gradual decrease of epidural pressure	1 second after the completion of entry from ligamentum flavum to epidural space
Secondary	factors contributing the epidural pressure pattern	factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern	60 minutes after the completion of entry from ligamentum flavum to epidural space