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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Fluoroscopic-guided cervical epidural access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoroscopic-guided cervical epidural access<br>Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance. | Procedure: Fluoroscopic-guided cervical epidural access<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dural puncture event - major complication | whether a dural puncture event occurs or not during the cervical epidural access | Immediately after contrast medium administration during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications | intravascular entry, subdural entry, vasovagal reaction, spinal cord injury | Immediately after procedure | 
| Needling time | time to access the epidural space after skin insertion | Immediately after procedure | 
| First attempt success | whether an cervical epidural access is successful at once without any withdrawal of the needle or not | Immediately after procedure | 
| 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. | Immediately after procedure | 
| Rate of success or failure | Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space. | Immediately after procedure | 
| 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). | One day after the procedure | 
| 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) | One day after the procedure | 
| 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 | Immediately after procedure | 
| Post-procedural complication | epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache | Up to one month after the procedure | 
| Radiation dose (cGy) | Radiation dose (cGy) | Immediately after procedure | 
| 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). | One month after the procedure | 
| 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) | One month after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluoroscopy, contralateral oblique view, cervical epidural block, cervical epidural space