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

Migraine Disorders Clinical Trial

— GON  

Official title:

Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02578719
• Other study ID #: B.10.4.ISM.4.06.68.49/
• Status: Withdrawn
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: January 19, 2018
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• bupivacaine
marcaine %0.5 20 ml flacon
• saline
%0.9 sodium chloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

References & Publications (1)

Inan LE, Inan N, Karadas Ö, Gül HL, Erdemoglu AK, Türkel Y, Akyol A. Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study. Acta Neurol Scand. 2015 Oct;132(4):270-7. doi: 10.1111/ane.12393. Epub 2015 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50% decrease in migraine severity		6 months