NCT07763678

Brief Summary

Migraine is one of the most prevalent neurological disorders worldwide and remains a leading cause of disability, particularly among individuals of working age. Chronic migraine affects approximately 1-2% of the global population and is associated with substantial impairment in quality of life, reduced work productivity, and increased healthcare utilization . Despite recent advances in migraine management, including calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies and gepants, many patients continue to experience inadequate symptom control, treatment intolerance, or limited access to these therapies . Consequently, peripheral nerve blocks have emerged as effective non-pharmacological treatment options for patients with refractory migraine and other primary headache disorders . Among the available interventional techniques, the greater occipital nerve block (GONB) is one of the most widely used procedures for both acute and preventive treatment of migraine. The therapeutic effect of GONB is believed to result from modulation of nociceptive transmission within the trigeminocervical complex, thereby reducing central sensitization and interrupting convergence between cervical and trigeminal afferents. Several randomized clinical trials and systematic reviews have demonstrated that GONB significantly reduces headache intensity, headache frequency, analgesic consumption, and migraine-related disability while maintaining an excellent safety profile . Migraine pain often involves overlapping sensory territories supplied by interconnected peripheral nerves. The greater auricular nerve (GAN), a superficial sensory branch of the cervical plexus arising from the C2 and C3 spinal nerves, supplies the skin over the parotid region, mastoid process, lower auricle, and angle of the mandible . Because cervical sensory afferents converge with trigeminal nociceptive pathways within the trigeminocervical complex, the GAN may contribute to peripheral nociceptive transmission involved in migraine pathophysiology . Combined blockade of multiple cervical sensory nerves may therefore provide broader interruption of peripheral nociceptive input, potentially enhancing analgesic efficacy and reducing central sensitization . Ultrasound-guided GONB has been shown to produce greater procedural accuracy and consistent clinical outcomes than landmark-guided techniques . Despite the increasing use of peripheral nerve blocks in headache medicine, evidence regarding the additional benefit of combining a greater auricular nerve block with the standard greater occipital nerve block remains limited. To the best of our knowledge, no prospective randomized double-blind clinical trial has directly compared ultrasound-guided combined GONB and GAN block with GONB alone in patients with chronic migraine.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
15mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) pain score

    change in Visual Analog Scale (VAS) pain score .the Visual Analogue Scale (VAS) for pain is a continuous 10-centimeter (100 mm) line with word anchors at each end. The left side reads "no pain" (0) and the right side reads "worst imaginable pain" (10 or 100). Patients make a mark on the line to show their pain level

    30 days

Study Arms (2)

GONB group

ACTIVE COMPARATOR

Patients will receive bilateral ultrasound-guided greater occipital nerve block using a standardized ultrasound-guided technique

Procedure: greater occipital nerve block

GONB + GAN group

ACTIVE COMPARATOR

Patients will receive bilateral ultrasound-guided combined greater occipital nerve block and greater auricular nerve block. Ultrasound guidance will be used to optimize needle placement, improve local anesthetic distribution, and minimize complications

Procedure: greater occipital nerve blockProcedure: Greater Auricular Nerve Block

Interventions

The greater occipital nerve will be identified between the obliquus capitis inferior and semispinalis capitis muscles at the C2 level. An in-plane lateral-to-medial approach will be used. Following negative aspiration, the study solution will be injected around the nerve under real-time ultrasound guidance

GONB + GAN groupGONB group

the greater auricular nerve will be identified superficially over the sternocleidomastoid muscle at the level of the cricoid cartilage. Using an in-plane approach and after negative aspiration, the study solution will be injected circumferentially around the nerve under ultrasound guidance.

GONB + GAN group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years.
  • Diagnosis of chronic migraine according to ICHD-3 criteria (1).
  • Patients free from major neurological or psychiatric disorders that may interfere with headache assessment or study participation (3,4).
  • Ability to provide written informed consent and comply with study procedures.

You may not qualify if:

  • Age \<18 years.
  • Medication-overuse headache according to ICHD-3 criteria .
  • Acute migraine medication use within 24 hours before intervention .
  • Previous trauma or surgery involving the occipital region .
  • Known hypersensitivity to local anesthetic agents.
  • Local skin infection, dermatological disease, or impaired occipital sensation at the injection site.
  • Bleeding diathesis, anticoagulan؛t therapy, or skull defect contraindicating peripheral nerve block .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at Anesthesia, Intensive Care and Pain Management

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08