Recruiting
Early Phase 1

Nerve Block & Oral Dexamethasone

Sponsor:

Texas Tech University Health Sciences Center, El Paso

Code:

NCT06016465

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Oral

Placebo

Study Details

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.

Conditions

Migraine

Study ID

NCT06016465

Start date

Sep 15, 2023

Status verified date

Apr, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dexamethasone

single oral dose of dexamethasone (8mg)

placebo comparator: Placebo

Single oral dose of placebo pill

Interventions

Dexamethasone Oral

Two 4mg pills

Placebo

2 placebo pills

Primary outcome measure

  • Recurrence of headache [ Time Frame: 72-96 hours post treatment ]

Central Contacts and Locations

Central contacts

Edward Michelson, MD

915 215 4600edward.michelson@ttuhsc.edu

Locations

University Medical Center of El Paso

Recruiting

El Paso, Texas, United States, 79905

Contacts

Leann Rodriguez

(915) 215-4976rod72863@ttuhsc.edu

Principal Investigator:

Edward A Michelson, MD

More Information

Sponsor

Texas Tech University Health Sciences Center, El Paso

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • migraine headache
  • peripheral nerve block
  • dexamethasone
  • steroid treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center, El Paso on 2026-05-06.