Factors Contributing to the Pressure Wave Form Changes

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

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.

Study Overview

• Status: Completed
• Conditions: Analysis, Event History
• Intervention / Treatment: Procedure: lumbar epidural injection

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700712
    • Ji Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumbar ESI with paramedian approach	Procedure: lumbar epidural injection; the pattern of pressure decrease from ligamentum flavum to epidural space
Active Comparator: Lumbar ESI with midline approach	Procedure: lumbar epidural injection; the pattern of pressure decrease from ligamentum flavum to epidural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cervical epidural space; abrupt pressure decrease
• Other Study ID Numbers: 2017-05-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No