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

Not Applicable

Completed

• Conditions: Cervical Radicular Pain; Cervical Spinal Stenosis; Cervical Intervertebral Disc Disease; Herpes Zoster; Postherpetic Neuralgia
• Interventions: Procedure: Fluoroscopic-guided cervical epidural access

• Registration Number: NCT04774458
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Study Start: 2021-03-04
• Primary Completion: 2022-07-28
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluoroscopic-guided cervical epidural access	Fluoroscopic-guided cervical epidural access	Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.

Primary Outcome Measures

Name	Time	Method
Dural puncture event - major complication	Immediately after contrast medium administration during the procedure	whether a dural puncture event occurs or not during the cervical epidural access

Secondary Outcome Measures

Name	Time	Method
Rate of success or failure	Immediately after procedure	Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.
Needle tips location	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)
Needling time	Immediately after procedure	time to access the epidural space after skin insertion
First attempt success	Immediately after procedure	whether an cervical epidural access is successful at once without any withdrawal of the needle or not
False positive/negative loss of resistance	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
Radiation dose (cGy)	Immediately after procedure	Radiation dose (cGy)
Total number of needle passes	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.
Needle tip visualization	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).
Post-procedural complication	Up to one month after the procedure	epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
Global perceived effect (GPE)	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)
Other complications	Immediately after procedure	intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
Numerical rating scales (NRS)	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).

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of