Anesthetic Blockades and Migraine

Phase 2

Completed

• Conditions: Chronic Migraine; Pain
• Interventions: Drug: Anesthetic blockades with bupivacaine; Drug: Isotonic saline injection

• Registration Number: NCT02188394
• Lead Sponsor: César Fernández-de-las-Peñas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Chronic migraine

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthetic blockades with bupivacaine	Anesthetic blockades with bupivacaine	Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
Isotonic saline injection	Isotonic saline injection	Patients will receive a bilateral occipital injection with isotonic saline

Primary Outcome Measures

Name	Time	Method
Changes in the number of days with moderate/intense migraine	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

Name	Time	Method
Changes in pressure pain thresholds	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
Changes in the number of symptomatic medication drugs	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 the number of days with mild/moderate migraine	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)

Trial Locations

Locations (1)

Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain