- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774458
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluoroscopic-guided cervical epidural access
Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dural puncture event - major complication
Time Frame: Immediately after contrast medium administration during the procedure
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whether a dural puncture event occurs or not during the cervical epidural access
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Immediately after contrast medium administration during the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other complications
Time Frame: Immediately after procedure
|
intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
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Immediately after procedure
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Needling time
Time Frame: Immediately after procedure
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time to access the epidural space after skin insertion
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Immediately after procedure
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First attempt success
Time Frame: Immediately after procedure
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whether an cervical epidural access is successful at once without any withdrawal of the needle or not
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Immediately after procedure
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Total number of needle passes
Time Frame: 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.
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Immediately after procedure
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Rate of success or failure
Time Frame: Immediately after procedure
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Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.
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Immediately after procedure
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Needle tip visualization
Time Frame: One day after the procedure
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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).
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One day after the procedure
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Needle tips location
Time Frame: One day after the procedure
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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)
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One day after the procedure
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False positive/negative loss of resistance
Time Frame: Immediately after procedure
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False positive: Not reaching epidural space despite feeling loss of resistance/ false negative: Reaching epidural space despite not feeling loss of resistance
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Immediately after procedure
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Post-procedural complication
Time Frame: Up to one month after the procedure
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epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
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Up to one month after the procedure
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Radiation dose (cGy)
Time Frame: Immediately after procedure
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Radiation dose (cGy)
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Immediately after procedure
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Numerical rating scales (NRS)
Time Frame: One month after the procedure
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One month after the procedure, the pain intensity is assessed using a numeric rating scale (0: no pain, 10: unbearable pain).
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One month after the procedure
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Global perceived effect (GPE)
Time Frame: One month after the procedure
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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)
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One month after the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doo-Hwan Kim, MD, PhD, Assistant Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Virus Diseases
- Infections
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- DNA Virus Infections
- Spinal Diseases
- Bone Diseases
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Neuralgia
- Herpes Zoster
- Spinal Stenosis
- Neuralgia, Postherpetic
Other Study ID Numbers
- 2021-0197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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