NCT02188394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

July 10, 2014

Last Update Submit

January 3, 2016

Conditions

Chronic MigrainePain

Keywords

migraine,pressure pain,anesthetic blockspatients

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Changes in the number of days with mild/moderate migraine

    Baseline (1 week before) and 1 week after intervention

  • Changes in the number of symptomatic medication drugs

    Baseline (1 week before) and 1 week after intervention

  • Changes in pressure pain thresholds

    Baseline, 1 hour after and 1 week after intervention

Study Arms (2)

Anesthetic blockades with bupivacaine

EXPERIMENTAL

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

Drug: Anesthetic blockades with bupivacaine

Isotonic saline injection

PLACEBO COMPARATOR

Patients will receive a bilateral occipital injection with isotonic saline

Drug: Isotonic saline injection

Interventions

Anesthetic blockades with bupivacaineDRUG
Anesthetic blockades with bupivacaine
Isotonic saline injectionDRUG
Isotonic saline injection

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic migraine

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid

Madrid, Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27296456DERIVED

MeSH Terms

Conditions

PainMigraine Disorders

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Maria Luz Cuadrado, MD; PhD

    Hospital Clinico San Carlos-Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 11, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

ES(1)