The aim of the present study is to investigate the safety and clinical utility of contralateral oblique view for fluoroscopic guided cervical epidural access.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
439
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.
Asan medical center
Seoul, South Korea
Dural puncture event - major complication
whether a dural puncture event occurs or not during the cervical epidural access
Time frame: Immediately after contrast medium administration during the procedure
Other complications
intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
Time frame: Immediately after procedure
Needling time
time to access the epidural space after skin insertion
Time frame: Immediately after procedure
First attempt success
whether an cervical epidural access is successful at once without any withdrawal of the needle or not
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: One day after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
Time frame: 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
Time frame: Immediately after procedure
Post-procedural complication
epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
Time frame: Up to one month after the procedure
Radiation dose (cGy)
Radiation dose (cGy)
Time frame: 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).
Time frame: 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)
Time frame: One month after the procedure