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

Primary Purpose

Cervical Intervertebral Disc Disease, Cervical Spinal Stenosis, Cervical Radicular Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluoroscopic-guided cervical epidural access
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intervertebral Disc Disease focused on measuring fluoroscopy, contralateral oblique view, cervical epidural block, cervical epidural space

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluoroscopic-guided cervical epidural access

Arm Description

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

Outcomes

Primary Outcome Measures

Dural puncture event - major complication
whether a dural puncture event occurs or not during the cervical epidural access

Secondary Outcome Measures

Other complications
intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
Needling time
time to access the epidural space after skin insertion
First attempt success
whether an cervical epidural access is successful at once without any withdrawal of the needle or not
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.
Rate of success or failure
Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.
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).
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)
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
Post-procedural complication
epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
Radiation dose (cGy)
Radiation dose (cGy)
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).
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)

Full Information

First Posted
February 21, 2021
Last Updated
September 6, 2022
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04774458
Brief Title
Prospective Observation of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View
Official Title
The Safety and Clinical Utilities of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View: a Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intervertebral Disc Disease, Cervical Spinal Stenosis, Cervical Radicular Pain, Herpes Zoster, Postherpetic Neuralgia
Keywords
fluoroscopy, contralateral oblique view, cervical epidural block, cervical epidural space

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopic-guided cervical epidural access
Arm Type
Experimental
Arm Description
Cervical epidural access with loss of resistance technique using CLO view at 50 degree under fluoroscopic guidance.
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopic-guided cervical epidural access
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dural puncture event - major complication
Description
whether a dural puncture event occurs or not during the cervical epidural access
Time Frame
Immediately after contrast medium administration during the procedure
Secondary Outcome Measure Information:
Title
Other complications
Description
intravascular entry, subdural entry, vasovagal reaction, spinal cord injury
Time Frame
Immediately after procedure
Title
Needling time
Description
time to access the epidural space after skin insertion
Time Frame
Immediately after procedure
Title
First attempt success
Description
whether an cervical epidural access is successful at once without any withdrawal of the needle or not
Time Frame
Immediately after procedure
Title
Total number of needle passes
Description
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
Title
Rate of success or failure
Description
Success is defined when contrast medium spreads appropriately in epidural space after physician successfully access cervical epidural space.
Time Frame
Immediately after procedure
Title
Needle tip visualization
Description
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
Title
Needle tips location
Description
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
Title
False positive/negative loss of resistance
Description
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
Title
Post-procedural complication
Description
epidural hematoma, spinal cord injury, infection, abscess, facial flushing, post-dural puncture headache
Time Frame
Up to one month after the procedure
Title
Radiation dose (cGy)
Description
Radiation dose (cGy)
Time Frame
Immediately after procedure
Title
Numerical rating scales (NRS)
Description
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
Title
Global perceived effect (GPE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo-Hwan Kim, MD, PhD
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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