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Anesthetic Blockades and Migraine

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ClinicalTrials.gov Identifier: NCT02188394
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Changes in the number of days with moderate/intense migraine [ Time Frame: Baseline, 1 hour after 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 6 points on a numerical pain rate scale (NPRS, 0-10)
Change History Complete list of historical versions of study NCT02188394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Changes in the number of days with mild/moderate migraine [ Time Frame: Baseline, 1 hour after 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)
  • Changes in the number of preventive medication drugs [ Time Frame: Baseline and 1 week after intervention ]
    The subjects will register in the headache diary the number of day per week which they need preventive medical drugs for relief the headache attack
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anesthetic Blockades and Migraine
Official Title  ICMJE Effects of Anesthetic Blockades on Pain Modulation in Migraine
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Migraine
  • Pain
Intervention  ICMJE
  • Drug: Anesthetic blockades with bupivacaine
  • Drug: Isotonic saline injection
Study Arms  ICMJE
  • Experimental: Anesthetic blockades with bupivacaine
    Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
    Intervention: Drug: Anesthetic blockades with bupivacaine
  • Placebo Comparator: Isotonic saline injection
    Patients will receive a bilateral occipital injection with isotonic saline
    Intervention: Drug: Isotonic saline injection
Publications * Cuadrado ML, Aledo-Serrano Á, Navarro P, López-Ruiz P, Fernández-de-Las-Peñas C, González-Suárez I, Orviz A, Fernández-Pérez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic migraine

Exclusion Criteria:

  • Other primary headaches
  • Other secondary headaches
  • Co-morbid medical diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188394
Other Study ID Numbers  ICMJE HCSC11/263
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Study Sponsor  ICMJE César Fernández-de-las-Peñas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Luz Cuadrado, MD; PhD Hospital Clinico San Carlos-Universidad Complutense de Madrid
PRS Account Universidad Rey Juan Carlos
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP