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Cervical Intervertebral Disc DiseaseNCT04774458

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

A study testing Fluoroscopic-guided cervical epidural access in people with Cervical Intervertebral Disc Disease and Cervical Spinal Stenosis, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
Fluoroscopic-guided cervical epidural access
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
1 siteSouth Korea
Study dates
4 Mar 2021to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan medical center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Fluoroscopic-guided cervical epidural access
Keywords
fluoroscopy, contralateral oblique view, cervical epidural block, cervical epidural space
Medical subject headings
Herpes Zoster, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroscopic-guided cervical epidural accessProcedure or surgery

    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.

Study groups in NCT04774458
Study groupRoleWhat they receive
Fluoroscopic-guided cervical epidural accessExperimentalCervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.
Receives: Procedure: Fluoroscopic-guided cervical epidural access

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dural puncture event - major complication

    whether a dural puncture event occurs or not during the cervical epidural access

    Measured: Immediately after contrast medium administration during the procedure

Secondary outcomes (12)

  1. Other complications

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

    Measured: Immediately after procedure

  2. Needling time

    time to access the epidural space after skin insertion

    Measured: Immediately after procedure

  3. First attempt success

    whether an cervical epidural access is successful at once without any withdrawal of the needle or not

    Measured: Immediately after procedure

  4. Total number of needle passes

    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.

    Measured: Immediately after procedure

  5. Rate of success or failure

    Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.

    Measured: Immediately after procedure

  6. Needle tip visualization

    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).

    Measured: One day after the procedure

  7. Needle tips location

    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)

    Measured: One day after the procedure

  8. False positive/negative loss of resistance

    False positive: Not reaching epidural space despite feeling loss of resistance/ false negative: Reaching epidural space despite not feeling loss of resistance

    Measured: Immediately after procedure

  9. Post-procedural complication

    epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache

    Measured: Up to one month after the procedure

  10. Radiation dose (cGy)

    Radiation dose (cGy)

    Measured: Immediately after procedure

  11. Numerical rating scales (NRS)

    One month after the procedure, the pain intensity is assessed using a numeric rating scale (0: no pain, 10: unbearable pain).

    Measured: One month after the procedure

  12. Global perceived effect (GPE)

    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)

    Measured: One month after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start4 Mar 2021
  3. Primary completion28 Jul 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04774458
Sponsor's protocol ID
2021-0197
Status last verified
Sep 2022
First submitted
21 Feb 2021
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Kwon HJ, Kim CS, Kim J, Kim S, Shin JY, Choi SS, Shin JW, Kim DH. Contralateral oblique view can prevent dural puncture in fluoroscopy-guided cervical epidural access: a prospective observational study. Reg Anesth Pain Med. 2023 Dec;48(12):588-593. doi: 10.1136/rapm-2022-104297. Epub 2023 Apr 6.

    PubMed 37024268

Questions about this trial

What is this clinical trial studying?

A study testing Fluoroscopic-guided cervical epidural access in people with Cervical Intervertebral Disc Disease and Cervical Spinal Stenosis, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dural puncture event - major complication (time frame: Immediately after contrast medium administration during the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04774458, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.

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