Predictors of GON Blockade Success in Migraine

Başakşehir Çam & Sakura City Hospital

Status: Not yet enrolling

Conditions: Migraine

Treatments: Procedure: Greater Occipital Nerve (GON) Blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT07170111

25.06.2025.242

Details and patient eligibility

About

This multicenter, prospective cohort study aims to identify clinical and demographic predictors that influence the success of greater occipital nerve (GON) block in patients with migraine.

Patients will be evaluated at baseline, on each injection day, and at one- and three-month follow-ups. Study parameters include demographics, migraine type and duration, comorbidities, headache characteristics, treatment history, and validated outcome measures such as the Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6), and Global Rating of Change (GRoC).

The goal is to establish predictive factors of treatment success in order to optimize patient selection and contribute robust multicenter evidence to individualized migraine management

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of migraine for at least 6 months, according to ICHD-3 criteria
• Age between 18 and 65 years
• Inadequate response to preventive therapy used regularly for at least 3 months
• Planned treatment with greater occipital nerve block (GONB) and provision of signed informed consent
• Receiving GONB treatment for the first time

Exclusion criteria

• Pregnancy or breastfeeding
• Presence of malignancy
• Coagulopathy or anticoagulant therapy
• Local infection, open wound, or history of surgery at the injection site preventing the procedure
• History of severe neurological or psychiatric disorders
• Receipt of interventional treatment (e.g., Botox, acupuncture, neural therapy, nerve blocks) within the last 3 months
• Use of steroids or immunosuppressive therapy
• Start of a new preventive therapy within the last 3 months
• Inability to comply with keeping a headache diary
• Known hypersensitivity or allergy to bupivacaine

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

460 participants in 1 patient group

GON Block Group

Experimental group

Treatment:

Procedure: Greater Occipital Nerve (GON) Blockade