Clinical trial NCT04774458: Prospective Observation of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View
Official title: The Safety and Clinical Utilities of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View: a Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intervertebral Disc Disease
Cervical Spinal Stenosis
Cervical Radicular Pain
Herpes Zoster
Postherpetic Neuralgia
Keywords: fluoroscopy
contralateral oblique view
cervical epidural block
cervical epidural space
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 439
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Dural puncture event - major complication
timeFrame: Immediately after contrast medium administration during the procedure
Secondary outcomes:
measure: Other complications
timeFrame: Immediately after procedure
measure: Needling time
timeFrame: Immediately after procedure
measure: First attempt success
timeFrame: Immediately after procedure
measure: Total number of needle passes
timeFrame: Immediately after procedure
measure: Rate of success or failure
timeFrame: Immediately after procedure
measure: Needle tip visualization
timeFrame: One day after the procedure
measure: Needle tips location
timeFrame: One day after the procedure
measure: False positive/negative loss of resistance
timeFrame: Immediately after procedure
measure: Post-procedural complication
timeFrame: Up to one month after the procedure
measure: Radiation dose (cGy)
timeFrame: Immediately after procedure
measure: Numerical rating scales (NRS)
timeFrame: One month after the procedure
measure: Global perceived effect (GPE)
timeFrame: One month after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Assistant professor
name: Doo-Hwan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: