Trial | NCT02578719  Report issue

Title

Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.
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 Started
Jul 31
2016
Primary Completion
Jul 31
2018
Anticipated
Study Completion
Jul 31
2018
Anticipated
Last Update
Jan 23
2018

Drug bupivacaine

marcaine %0.5 20 ml flacon

  • Other names: marcaine

Drug saline

%0.9 sodium chloride

  • Other names: %0.9 sodium chloride

drug: bupivacaine Placebo Comparator

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.

placebo Placebo Comparator

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.

Criteria 

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.
No Results Posted