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Anesthetic Blockades and Migraine

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ClinicalTrials.gov Identifier: NCT02188394
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Pain Drug: Anesthetic blockades with bupivacaine Drug: Isotonic saline injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Anesthetic Blockades on Pain Modulation in Migraine
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Bupivacaine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anesthetic blockades with bupivacaine
Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
 Drug: Anesthetic blockades with bupivacaine
Placebo Comparator: Isotonic saline injection
Patients will receive a bilateral occipital injection with isotonic saline
 Drug: Isotonic saline injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic migraine

Exclusion Criteria:

  • Other primary headaches
  • Other secondary headaches
  • Co-morbid medical diseases
Contacts and Locations
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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): NCT02188394


Locations
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Spain
Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid
Madrid, Spain
Sponsors and Collaborators
César Fernández-de-las-Peñas
Investigators
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Principal Investigator: Maria Luz Cuadrado, MD; PhD Hospital Clinico San Carlos-Universidad Complutense de Madrid
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: César Fernández-de-las-Peñas, Proffesor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02188394    
Other Study ID Numbers: HCSC11/263
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by César Fernández-de-las-Peñas, Universidad Rey Juan Carlos:
migraine,
pressure pain,
anesthetic blocks
patients
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
 Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents