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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774458
• Other study ID #: 2021-0197
• Status: Completed
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: August 31, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Fluoroscopic-guided cervical epidural access
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other complications	intravascular entry, subdural entry, vasovagal reaction, spinal cord injury	Immediately after procedure
Secondary	Needling time	time to access the epidural space after skin insertion	Immediately after procedure
Secondary	First attempt success	whether an cervical epidural access is successful at once without any withdrawal of the needle or not	Immediately after procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-procedural complication	epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache	Up to one month after the procedure
Secondary	Radiation dose (cGy)	Radiation dose (cGy)	Immediately after procedure
Secondary	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
Secondary	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