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OpenTrials
Completed

NCT Number: NCT02188394

Anesthetic Blockades and Migraine

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.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic migraine

Exclusion criteria

  • Other primary headaches
  • Other secondary headaches
  • Co-morbid medical diseases

Treatment and study plan

Anesthetic blockades with bupivacaine

Drug

Isotonic saline injection

Drug

Primary outcomes

  1. Changes in the number of days with moderate/intense migraine

    Time frame: Baseline (1 week before) and 1 week after intervention

    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)

Secondary outcomes

  1. Changes in the number of days with mild/moderate migraine

    Time frame: Baseline (1 week before) and 1 week after intervention

    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)

  2. Changes in the number of symptomatic medication drugs

    Time frame: Baseline (1 week before) and 1 week after intervention

    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

  3. Changes in pressure pain thresholds

    Time frame: Baseline, 1 hour after and 1 week after intervention

    Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle

Sponsors and collaborators

Lead sponsor

César Fernández-de-las-Peñas

Other

Registry information

Official study title

Effects of Anesthetic Blockades on Pain Modulation in Migraine

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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