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NCT Number: NCT06016465

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Medical Center of El Paso

El Paso, Texas, 79905, United States

Location status: Recruiting

Location contact

Edward A Michelson, MD

PRINCIPAL_INVESTIGATOR

Leann Rodriguez

CONTACT

[email protected]

(915) 215-4976

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone Oral

Drug

Two 4mg pills

Other names: Decadron

Placebo

Drug

2 placebo pills

Other names: Dextrose methyl cellulose

Primary outcomes

  1. Recurrence of headache

    Time frame: 72-96 hours post treatment

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

Secondary outcomes

  1. Early recurrence headache and timing

    Time frame: 72-96hrs post treatment

    HA severity, location, time since enrollment enrollment,medications

  2. side effects of dexamethasone identified if any

    Time frame: 72-96 hrs post treatment

    elevation in glucose level, other symptoms associated with corticosteroids

Study contacts

Contact information is provided by the study sponsor or research team.

Edward Michelson, MD

CONTACT

[email protected]

915 215 4600

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 29, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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