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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774458
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Doo-Hwan Kim, Asan Medical Center

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

Condition or disease Intervention/treatment Phase
Cervical Intervertebral Disc Disease Cervical Spinal Stenosis Cervical Radicular Pain Herpes Zoster Postherpetic Neuralgia Procedure: Fluoroscopic-guided cervical epidural access Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Clinical Utilities of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View: a Prospective Observational Study
Actual Study Start Date : March 4, 2021
Actual Primary Completion Date : July 28, 2022
Actual Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Procedure: Fluoroscopic-guided cervical epidural access
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774458


Locations
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Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Doo-Hwan Kim, MD, PhD Assistant professor
More Information
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Responsible Party: Doo-Hwan Kim, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04774458    
Other Study ID Numbers: 2021-0197
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Doo-Hwan Kim, Asan Medical Center:
fluoroscopy
contralateral oblique view
cervical epidural block
cervical epidural space
Additional relevant MeSH terms:
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Herpes Zoster
Spinal Stenosis
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections