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

NCT ID: NCT04774458

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 439 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2022-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoroscopic-guided cervical epidural access

Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.

Group Type: EXPERIMENTAL

Fluoroscopic-guided cervical epidural access

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Doo-Hwan Kim

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doo-Hwan Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

References

Kwon HJ, Kim CS, Kim J, Kim S, Shin JY, Choi SS, Shin JW, Kim DH. Contralateral oblique view can prevent dural puncture in fluoroscopy-guided cervical epidural access: a prospective observational study. Reg Anesth Pain Med. 2023 Dec;48(12):588-593. doi: 10.1136/rapm-2022-104297. Epub 2023 Apr 6.

Reference Type: DERIVED

PMID: 37024268 (View on PubMed)

Other Identifiers

2021-0197

Identifier Type: -

Identifier Source: org_study_id