- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02578719
Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up (GON)
January 19, 2018 updated by: Levent E. Inan, Bozok University
Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
marcaine %0.5 20 ml flacon
Other Names:
|
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.
|
%0.9 sodium chloride
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
50% decrease in migraine severity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Levent E Inan, Prof., Bozok University Neurology Department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
October 8, 2015
First Submitted That Met QC Criteria
October 16, 2015
First Posted (Estimate)
October 19, 2015
Study Record Updates
Last Update Posted (Actual)
January 23, 2018
Last Update Submitted That Met QC Criteria
January 19, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- B.10.4.ISM.4.06.68.49/
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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