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Clinical Trials/NCT07763678
NCT07763678Not yet recruitingPhase 4

Efficacy of Ultrasound-Guided Combined Greater Occipital Nerve Block and Greater Auricular Nerve Block Versus Greater Occipital Nerve Block Alone in the Management of Chronic Migraine

Assiut University0 sites80 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
80
Primary Endpoint
Visual Analog Scale (VAS) pain score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Masking Description

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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 .

Arms & Interventions

GONB group

Active Comparator

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

Intervention: greater occipital nerve block (Procedure)

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

Intervention: greater occipital nerve block (Procedure)

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

Intervention: Greater Auricular Nerve Block (Procedure)

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) pain score

Time Frame: 30 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mostafa Ahmed Mamdouh

Resident doctor at Anesthesia, Intensive Care and Pain Management

Assiut University

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