Great Occipital Nerve Block Using Different Approach

November 28, 2023 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

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

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Recruiting

Conditions

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Intervention / Treatment

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Interventional

Enrollment (Estimated)

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24

Phase

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  • Not Applicable

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Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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Intervention / Treatment

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A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: interfascial plane group
injection into inferfascial plane
Procedure: Greater occipital nerve block
Greater occipital nerve block using ultrasound guidance
Experimental: intramuscular group
injection into obliqus capitis inferior muscle
Procedure: Greater occipital nerve block
Greater occipital nerve block using ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

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Sponsor

Sponsor

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Keimyung University Dongsan Medical Center

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

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November 13, 2023

Primary Completion (Estimated)

Primary Completion

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June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

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November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-10-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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