- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06149299
Great Occipital Nerve Block Using Different Approach
Comparison of Pain Relief and Block Success of Great Occipital Nerve Block Using Different Approach Method at C2 Level
Great occipital nerve (GON) block is commonly applied for the pain management of occipital neuralgia, migraine, and cervicogenic headache. The GON orginates from the medial branch of the dorsal ramus of the C2 spinal nerve with variable contribution from the C3 dorsal ramus. After emerging from the suboccipital triangle, the nerve courses cephalad in an oblique trajectory between the semispinalis capitis (SC) and obliqus capitis inferior (OCI) muscles. This area was recognized as a potential location for GON injury. The nerve then passes through the trapezius muscle and courses medial to the occipital artery as it ascends to innervate the posterior scalp.
Many practitioners perform GON injections using a conventional approach, relying solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line.
Some clinicians also use fluoroscopy to confirm the location of bony landmarks. The ambiguity of these injections poses a risk of anesthetizing adjacent structures or injecting into vessels, such as the occipital artery. Very limited research has been done to quantify the risk of these injections, but a complication rate of 5% to 10% has been reported, including headache, dizziness, blurred vision, and syncope.
Ultrasound guidance is increasingly used to mitigate these risks and improve the efficacy of GON injections. Multiple studies have demonstrated successful ultrasound-guided GON blockade at the superior nuchal line and improvement in pain scores compared with nonguided injections.
C2 level GON block using ultrasound targets interfascial plane between OCI and SC muscles. However, a pain physician who begins ultrasound guided injections migth feel very difficult targeting interfascial plane exactly.
Since GON orginiates from deep space of suboccipital triangle, it is expected that injection within OCI muscle might have similar effect with the effect of injection into interfascial plane.
We assume that if the local anesthetics is injected within OCI muscle, the effect of GON block will be generated by the diffusion of injected local anesthetics.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ji H Hong
- Phone Number: +821046794343
- Email: swon13@daum.net
Study Locations
-
-
-
Daegu, Korea, Republic of, 42601
- Recruiting
- Hong Ji Hee
-
Contact:
- J Hee Hong
- Phone Number: 82-53-258-7767
- Email: swon13@daum.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cervicogenic headache
- Migraine
- Occipital neuralgia
Exclusion Criteria:
- bilateral headache
- cervical spine surgery within 1 year before
- loss of sensory sensation at the dermatome of GON innervation
- anatomical defect at the region of procedure
- coagulopathy
- pregnancy or breast feeding
- allergy to local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: interfascial plane group
injection into inferfascial plane
|
Greater occipital nerve block using ultrasound guidance
|
|
Experimental: intramuscular group
injection into obliqus capitis inferior muscle
|
Greater occipital nerve block using ultrasound guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale
Time Frame: Baseline, 30 minutes, 2 weeks, 4 weeks after the completion of GON block
|
Numerical rating scale after GON block
|
Baseline, 30 minutes, 2 weeks, 4 weeks after the completion of GON block
|
|
block success
Time Frame: Baseline, 30 minutes after the completion of GON block
|
block success after GON block
|
Baseline, 30 minutes after the completion of GON block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Side effect after GON block
Time Frame: Baseline, 30 minutes after the completion of GON block
|
Side effect after GON block
|
Baseline, 30 minutes after the completion of GON block
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 2023-10-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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