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

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ClinicalTrials.gov Identifier: NCT02578719
Recruitment Status : Withdrawn (Local Drug Authority didn't give permission to start.)
First Posted : October 19, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Levent E. Inan, Bozok University

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

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: bupivacaine Drug: saline Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: 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.
Drug: bupivacaine
marcaine %0.5 20 ml flacon
Other Name: marcaine

Placebo Comparator: 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.
Drug: saline
%0.9 sodium chloride
Other Name: %0.9 sodium chloride




Primary Outcome Measures :
  1. 50% decrease in migraine severity [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578719


Sponsors and Collaborators
Bozok University
Investigators
Principal Investigator: Levent E Inan, Prof. Bozok University Neurology Department

Publications:
Responsible Party: Levent E. Inan, Professor, Bozok University
ClinicalTrials.gov Identifier: NCT02578719     History of Changes
Other Study ID Numbers: B.10.4.ISM.4.06.68.49/
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents