Prospective Observation of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View

September 6, 2022 updated by: Doo-Hwan Kim, Asan Medical Center

The Safety and Clinical Utilities of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View: a Prospective Observational Study

The aim of the present study is to investigate the safety and clinical utility of contralateral oblique view for fluoroscopic guided cervical epidural access.

Study Overview

Detailed Description

A cervical epidural block is a widely used intervention to reduce pain in patients with cervicalgia or cervical radicular pain. To achieve a successful procedure, accurate access to the cervical epidural space is needed. However, careful attention is required for this cervical epidural procedure due to a possibility of serious complications such as spinal cord infarction and quadriplegia due to blood vessel damage, convulsion due to an intravascular drug administration, cerebral infarction due to vascular embolism, subdural or subarachnoid injection, hematoma, and spinal cord injury. Although the use of fluoroscopy improves the safety and accuracy of cervical epidural access, this technique still has significant drawbacks, such as false loss of resistance and difficulty in assessing the depth of the needle tip in lateral views in relation to the epidural space. To overcome this issue, cervical epidural access using the contralateral oblique (CLO) view has been introduced and the ideal angle of CLO view for the cervical spine is reported as 50 degrees.

However, it has not been reported on the safety and clinical utility of using the CLO view during cervical epidural access. Therefore, the investigators planned this study to observe the safety and clinical utility of the CLO view at 50 degrees for the cervical epidural block.

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who need an epidural space access at C6-7 or C7-T1 level
  • Patients who are expected to undergo cervical epidural block
  • Patients who are expected to undergo cervical epidural neuroplasty
  • 20 ≤ age <80
  • When obtaining informed consent voluntarily

Exclusion Criteria:

  • Allergy to local anesthetics and contrast dye, and steroid
  • Use of anticoagulants or antiplatelet medication, coagulopathy
  • Infection at the insertion site
  • Neurological or psychiatric disorders
  • Prior spine instrumentation
  • Pregnancy
  • Not visible epidural space due to severe cervical spinal canal stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoroscopic-guided cervical epidural access
Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.
After identifying the target level of the cervical spine under a fluoroscopy-guided anteroposterior image, an 18-Tuohy needle is inserted through a paramedian approach after local infiltration with 1% lidocaine. When feeling a strong resistance through the needle by a ligamentum flavum, the image intensifier is rotated to 50 degrees contralateral oblique (CLO) direction. After then, the needle is advanced to just before the ventral interlaminar line in CLO view. It is subsequently advanced further until it is in the epidural space using a LOR-to-air technique. Correct epidural access is confirmed by the injection of contrast medium. After identifying epidural space in AP and CLO view without abnormal dispersion of contrast,(vascular uptake, intrathecal spreads, etc.), a 3-4ml mixture of 0.5% lidocaine with dexamethasone 5mg is injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dural puncture event - major complication
Time Frame: Immediately after contrast medium administration during the procedure
whether a dural puncture event occurs or not during the cervical epidural access
Immediately after contrast medium administration during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other complications
Time Frame: Immediately after procedure
intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
Immediately after procedure
Needling time
Time Frame: Immediately after procedure
time to access the epidural space after skin insertion
Immediately after procedure
First attempt success
Time Frame: Immediately after procedure
whether an cervical epidural access is successful at once without any withdrawal of the needle or not
Immediately after procedure
Total number of needle passes
Time Frame: Immediately after procedure
A needle pass is considered as an advancement of the needle without any withdrawal. If the needle is re-advanced after a withdrawal, it is considered as an additional(second) needle pass.
Immediately after procedure
Rate of success or failure
Time Frame: Immediately after procedure
Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.
Immediately after procedure
Needle tip visualization
Time Frame: One day after the procedure
The clarity of the needle tip was subjectively graded as 1 (clearly visualized without ambiguity), 2 (poorly visualized or visualized with effort), or 3 (not visualized).
One day after the procedure
Needle tips location
Time Frame: One day after the procedure
Location of the needle tip was defined as being significantly before the VILL(Ventral interlaminar line) (-2), just before the VILL (-1), on the VILL (0), just after the VILL (+1), or significantly after the VILL (+2)
One day after the procedure
False positive/negative loss of resistance
Time Frame: Immediately after procedure
False positive: Not reaching epidural space despite feeling loss of resistance/ false negative: Reaching epidural space despite not feeling loss of resistance
Immediately after procedure
Post-procedural complication
Time Frame: Up to one month after the procedure
epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
Up to one month after the procedure
Radiation dose (cGy)
Time Frame: Immediately after procedure
Radiation dose (cGy)
Immediately after procedure
Numerical rating scales (NRS)
Time Frame: One month after the procedure
One month after the procedure, the pain intensity is assessed using a numeric rating scale (0: no pain, 10: unbearable pain).
One month after the procedure
Global perceived effect (GPE)
Time Frame: One month after the procedure
One month after the procedure, Patient satisfaction is assessed using global perceived effects on a 7-point scale (GPE). (1: very dissatisfied, 7: very satisfied)
One month after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Doo-Hwan Kim, MD, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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