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

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

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

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
Spain | |
Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid | |
Madrid, Spain |
Principal Investigator: | Maria Luz Cuadrado, MD; PhD | Hospital Clinico San Carlos-Universidad Complutense de Madrid |
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 |
migraine, pressure pain, anesthetic blocks patients |
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 |