Anesthetic Blockades and Migraine

January 3, 2016 updated by: César Fernández-de-las-Peñas

Effects of Anesthetic Blockades on Pain Modulation in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Chronic migraine

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
Baseline (1 week before) and 1 week after intervention
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
Baseline (1 week before) and 1 week after intervention
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
Baseline, 1 hour after and 1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

César Fernández-de-las-Peñas

Investigators

  • Principal Investigator: Maria Luz Cuadrado, MD; PhD, Hospital Clinico San Carlos-Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCSC11/263

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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