Great Occipital Nerve Block Using Different Approach

NCT06149299 | Unknown

• 1 other identifier: 2023-10-025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• Numerical rating scale

  Numerical rating scale after GON block

  Baseline, 30 minutes, 2 weeks, 4 weeks after the completion of GON block

• block success

  block success after GON block

  Baseline, 30 minutes after the completion of GON block

Secondary Outcomes (1)

• Side effect after GON block

  Baseline, 30 minutes after the completion of GON block

Study Arms (2)

interfascial plane group

PLACEBO COMPARATOR

injection into inferfascial plane

Procedure: Greater occipital nerve block

intramuscular group

EXPERIMENTAL

injection into obliqus capitis inferior muscle

Procedure: Greater occipital nerve block

Interventions

Greater occipital nerve block PROCEDURE

Greater occipital nerve block using ultrasound guidance

interfascial plane group; intramuscular group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervicogenic headache
• Migraine
• Occipital neuralgia

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ji H Hong

CONTACT

+821046794343; swon13@daum.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: November 13, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)