Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
Overview
- Phase
- Phase 4
- Intervention
- bupivacaine
- Conditions
- Migraine Disorders
- Sponsor
- Bozok University
- Primary Endpoint
- 50% decrease in migraine severity
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Levent E. Inan
Professor
Bozok University
Eligibility 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.
Arms & Interventions
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.
Intervention: bupivacaine
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.
Intervention: saline
Outcomes
Primary Outcomes
50% decrease in migraine severity
Time Frame: 6 months