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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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drug: 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.

Group Type PLACEBO_COMPARATOR

bupivacaine

Intervention Type DRUG

marcaine %0.5 20 ml flacon

placebo

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.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

%0.9 sodium chloride

Interventions

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bupivacaine

marcaine %0.5 20 ml flacon

Intervention Type DRUG

saline

%0.9 sodium chloride

Intervention Type DRUG

Other Intervention Names

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marcaine %0.9 sodium chloride

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No