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

This study is not yet open for participant recruitment.
Verified July 2016 by Levent E. Inan, Bozok University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02578719
First Posted: October 19, 2015
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Levent E. Inan, Bozok University
  Purpose
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

Condition Intervention Phase
Migraine Disorders Drug: bupivacaine Drug: saline Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Levent E. Inan, Bozok University:

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

Estimated Enrollment: 250
Study Start Date: July 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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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.
  Contacts and Locations
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


Contacts
Contact: Levent E Inan, Prof. 00905324149358 drleinan@yahoo.com

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

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 Submitted: October 8, 2015
First Posted: October 19, 2015
Last Update Posted: July 19, 2016
Last Verified: July 2016

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