Anesthetic Blockades and Migraine

Pain Clinical Trial

Official title:

Effects of Anesthetic Blockades on Pain Modulation in Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188394
• Other study ID #: HCSC11/263
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2014
• Last updated: January 3, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic migraine

Exclusion Criteria:

• Other primary headaches

• Other secondary headaches

• Co-morbid medical diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders
• Pain

Intervention

Drug:
• Anesthetic blockades with bupivacaine

• Isotonic saline injection

Locations

Country	Name	City	State
Spain	Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
César Fernández-de-las-Peñas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline (1 week before) and 1 week after intervention	Yes
Secondary	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)	Baseline (1 week before) and 1 week after intervention	Yes
Secondary	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	Baseline (1 week before) and 1 week after intervention	Yes
Secondary	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	Baseline, 1 hour after and 1 week after intervention	Yes