Anesthetic Blockades and Migraine

NCT ID: NCT02188394

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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Chronic Migraine Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anesthetic blockades with bupivacaine

Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%

Group Type EXPERIMENTAL

Anesthetic blockades with bupivacaine

Intervention Type DRUG

Isotonic saline injection

Patients will receive a bilateral occipital injection with isotonic saline

Group Type PLACEBO_COMPARATOR

Isotonic saline injection

Intervention Type DRUG

Interventions

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Anesthetic blockades with bupivacaine

Intervention Type DRUG

Isotonic saline injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic migraine

Exclusion Criteria

* Other primary headaches
* Other secondary headaches
* Co-morbid medical diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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César Fernández-de-las-Peñas

OTHER

Sponsor Role lead

Responsible Party

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César Fernández-de-las-Peñas

Proffesor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maria Luz Cuadrado, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos-Universidad Complutense de Madrid

Locations

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Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.

Reference Type DERIVED
PMID: 27296456 (View on PubMed)

Other Identifiers

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HCSC11/263

Identifier Type: -

Identifier Source: org_study_id

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