Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

Not Applicable

Completed

• Conditions: Migraine Disorders
• Interventions: Procedure: Lidocaine injections; Procedure: Saline injections

• Registration Number: NCT03435185
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Brief Summary

The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.

Detailed Description

A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to GON and SON in the blockade patients. Placebo patients received 2 ml 0.9% saline in the same way. Patients were blinded to kind of injection.

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2015-06-01
• Study Completion: 2016-06-01
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-15
• Results First Submitted: 2018-02-20
• Results First Submitted QC: 2019-05-19
• Results First Posted: 2019-07-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Lack of benefits 1 year from preventive treatment or intolerance to their treatments.
• 18 ≥ years old
• Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month.

Exclusion Criteria

• Patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery
• Allergies to local anesthetics
• Hemorrhagic diathesis
• Alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blockade Group	Lidocaine injections	Lidocaine injections. Procedure. Grater occipital nerve and supraorbital nerve were blocked with %2 lidocaine. These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.
Placebo Group	Saline injections	Saline injections. Procedure. Grater occipital nerve and supraorbital nerve were injected with saline.These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.

Primary Outcome Measures

Name	Time	Method
Change of Frequency of Headache	Patients were followed up from baseline to 2 months after first injection.	Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.
Change of Severity of Headache	Patients were followed up for 2 months from baseline after first injection.	Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome