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Anesthetic Blockades and Migraine

Primary Purpose

Chronic Migraine, Pain

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Anesthetic blockades with bupivacaine
Isotonic saline injection
Sponsored by
César Fernández-de-las-Peñas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring migraine,, pressure pain,, anesthetic blocks, patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic migraine

Exclusion Criteria:

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

Sites / Locations

  • Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anesthetic blockades with bupivacaine

Isotonic saline injection

Arm Description

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

Patients will receive a bilateral occipital injection with isotonic saline

Outcomes

Primary Outcome Measures

Changes in the number of days with moderate/intense migraine
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

Changes in the number of days with mild/moderate migraine
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
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
Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle

Full Information

First Posted
July 10, 2014
Last Updated
January 3, 2016
Sponsor
César Fernández-de-las-Peñas
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1. Study Identification

Unique Protocol Identification Number
NCT02188394
Brief Title
Anesthetic Blockades and Migraine
Official Title
Effects of Anesthetic Blockades on Pain Modulation in Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
César Fernández-de-las-Peñas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Pain
Keywords
migraine,, pressure pain,, anesthetic blocks, patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthetic blockades with bupivacaine
Arm Type
Experimental
Arm Description
Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
Arm Title
Isotonic saline injection
Arm Type
Placebo Comparator
Arm Description
Patients will receive a bilateral occipital injection with isotonic saline
Intervention Type
Drug
Intervention Name(s)
Anesthetic blockades with bupivacaine
Intervention Type
Drug
Intervention Name(s)
Isotonic saline injection
Primary Outcome Measure Information:
Title
Changes in the number of days with moderate/intense migraine
Description
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)
Time Frame
Baseline (1 week before) and 1 week after intervention
Secondary Outcome Measure Information:
Title
Changes in the number of days with mild/moderate migraine
Description
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)
Time Frame
Baseline (1 week before) and 1 week after intervention
Title
Changes in the number of symptomatic medication drugs
Description
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
Time Frame
Baseline (1 week before) and 1 week after intervention
Title
Changes in pressure pain thresholds
Description
Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle
Time Frame
Baseline, 1 hour after and 1 week after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic migraine Exclusion Criteria: Other primary headaches Other secondary headaches Co-morbid medical diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luz Cuadrado, MD; PhD
Organizational Affiliation
Hospital Clinico San Carlos-Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27296456
Citation
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.
Results Reference
derived

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Anesthetic Blockades and Migraine

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