Great Occipital Nerve Block Using Different Approach

Sponsor
Keimyung University Dongsan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06149299
Collaborator
(none)
24
1
2
7.6
3.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Greater occipital nerve block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Pain Relief and Block Success of Great Occipital Nerve Block Using Different Approach Method at C2 Level
Actual Study Start Date :
Nov 13, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Numerical rating scale [Baseline, 30 minutes, 2 weeks, 4 weeks after the completion of GON block]

    Numerical rating scale after GON block

  2. block success [Baseline, 30 minutes after the completion of GON block]

    block success after GON block

Secondary Outcome Measures

  1. Side effect after GON block [Baseline, 30 minutes after the completion of GON block]

    Side effect after GON block

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong ji HEE Daegu Korea, Republic of 42601

Sponsors and Collaborators

  • Keimyung University Dongsan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier:
NCT06149299
Other Study ID Numbers:
  • 2023-10-025
First Posted:
Nov 28, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023