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

A

Asan Medical Center

Status

Completed

Conditions

Postherpetic Neuralgia
Cervical Spinal Stenosis
Cervical Radicular Pain
Herpes Zoster
Cervical Intervertebral Disc Disease

Treatments

Procedure: Fluoroscopic-guided cervical epidural access

Study type

Interventional

Funder types

Other

Identifiers

NCT04774458
2021-0197

Details and patient eligibility

About

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

Full 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.

Enrollment

439 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

439 participants in 1 patient group

Fluoroscopic-guided cervical epidural access
Experimental group
Description:
Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.
Treatment:
Procedure: Fluoroscopic-guided cervical epidural access

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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