Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up

Phase 4

Withdrawn

• Conditions: Migraine Disorders
• Interventions: Drug: saline; Drug: bupivacaine

• Registration Number: NCT02578719
• Lead Sponsor: Bozok University

Brief Summary

This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

Detailed Description

The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region. The response to GON blockade was not simply dependent on the direct local anesthetic effect of the injection . The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.

Study Timeline

• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2016-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic migraine headache according to International Headache Society Classification Criteria
• Patients who are not using any prophylacting agent

Exclusion Criteria

• patients given similar treatments before
• pregnant women
• hereditary diseases causing bleeding
• patients who have intracranial tumor or operation in posterior fossa
• allergic reactions to local anesthetics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	saline	first 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
drug: bupivacaine	bupivacaine	Placebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.

Primary Outcome Measures

Name	Time	Method
50% decrease in migraine severity	6 months