Skip to main content
OpenTrials
Completed

NCT Number: NCT04774458

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Intervertebral Disc Disease Cervical Radicular Pain Cervical Spinal Stenosis DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postherpetic Neuralgia Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan medical center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoroscopic-guided cervical epidural access

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Other complications

    Time frame: Immediately after procedure

    intravascular entry, subdural entry, vasovagal reaction, spinal cord injury

  2. Needling time

    Time frame: Immediately after procedure

    time to access the epidural space after skin insertion

  3. 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

  4. 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.

  5. 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.

  6. 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).

  7. 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)

  8. 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

  9. 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

  10. Radiation dose (cGy)

    Time frame: Immediately after procedure

    Radiation dose (cGy)

  11. 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).

  12. 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)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.