Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?

Texas Tech University Health Sciences Center, El Paso (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Oral
  • Drug: Placebo
Early Phase 1

Detailed Description

Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral).

This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.

Study Design

Study Type:
Anticipated Enrollment :
84 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized 1:1 for study drug vs placeboRandomized 1:1 for study drug vs placebo
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
Primary Purpose:
Official Title:
Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
Anticipated Study Start Date :
Aug 28, 2023
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Sep 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone

single oral dose of dexamethasone (8mg)

Drug: Dexamethasone Oral
Two 4mg pills
Other Names:
  • Decadron
  • Placebo Comparator: Placebo

    Single oral dose of placebo pill

    Drug: Placebo
    2 placebo pills
    Other Names:
  • Dextrose methyl cellulose
  • Outcome Measures

    Primary Outcome Measures

    1. Recurrence of headache [72-96 hours post treatment]

      Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred

    Secondary Outcome Measures

    1. Early recurrence headache and timing [72-96hrs post treatment]

      HA severity, location, time since enrollment enrollment,medications

    2. side effects of dexamethasone identified if any [72-96 hrs post treatment]

      elevation in glucose level, other symptoms associated with corticosteroids

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Meet ICHD-3 Migraine Headache Criteria

    • Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2

    • Nerve block performed with bupivacaine 0.5%

    Exclusion Criteria:
    • Head trauma

    • Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)

    • Headache in the setting of viral syndrome

    • Chronically on steroids

    • Known allergy to dexamethasone

    • Unable to reach the patient by phone or text for follow-up

    • Gestational diabetes or other uncontrolled diabetes

    • Known to be immunocompromised

    Contacts and Locations


    Site City State Country Postal Code
    1 University Medical Center of El Paso El Paso Texas United States 79905

    Sponsors and Collaborators

    • Texas Tech University Health Sciences Center, El Paso


    • Study Director: Susan Watts, PhD., Texas Tech University Health Sciences Center, Department of Emergency Medicine

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Edward Michelson, MD, Professor and Chair Dept of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso Identifier:
    Other Study ID Numbers:
    • E23081
    First Posted:
    Aug 29, 2023
    Last Update Posted:
    Aug 29, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Keywords provided by Edward Michelson, MD, Professor and Chair Dept of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 29, 2023