Anesthetic Blockades and Migraine

Study Overview
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Brief Summary
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Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.

Official Title
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Effects of Anesthetic Blockades on Pain Modulation in Migraine

Conditions
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Chronic Migraine, Pain

Intervention / Treatment
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* Drug: Anesthetic blockades with bupivacaine
* Drug: Isotonic saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic migraine Exclusion Criteria: Other primary headaches Other secondary headaches Co-morbid medical diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthetic blockades with bupivacaine<br>Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5% | Drug: Anesthetic blockades with bupivacaine<br> <br> |
| Placebo Comparator: Isotonic saline injection<br>Patients will receive a bilateral occipital injection with isotonic saline | Drug: Isotonic saline injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the number of days with moderate/intense migraine | A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10) | Baseline (1 week before) and 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the number of days with mild/moderate migraine | A headache diary will register the number of days with mild/moderate migraine. Moderate/intense migraine is considered a headache with an intensity level under 4 points on a numerical pain rate scale (NPRS, 0-10) | Baseline (1 week before) and 1 week after intervention | 
| Changes in the number of symptomatic medication drugs | The subjects will register in the headache diary the number of days per week in which they need symptomatic medical drugs for relief the headache attack | Baseline (1 week before) and 1 week after intervention | 
| Changes in pressure pain thresholds | Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle | Baseline, 1 hour after and 1 week after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure pain,, anesthetic blocks, patients, migraine,