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Trials / Completed

CompletedNCT04774458

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
439 (actual)
Sponsor
Asan Medical Center · Academic / Other
Sex
All
Age
20 Years – 79 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREFluoroscopic-guided cervical epidural accessAfter 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.

Timeline

Start date
2021-03-04
Primary completion
2022-07-28
Completion
2022-08-31
First posted
2021-03-01
Last updated
2022-09-07

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04774458. Inclusion in this directory is not an endorsement.