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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Dexamethasone Oral; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Edward Michelson, MD; Phone Number: 915 215 4600; Email: edward.michelson@ttuhsc.edu

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Recruiting
      • University Medical Center of El Paso
      • Principal Investigator: Edward A Michelson, MD
      • Contact: Leann Rodriguez; Phone Number: (915) 215-4976; Email: rod72863@ttuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of headache	Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred	72-96 hours post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early recurrence headache and timing	HA severity, location, time since enrollment enrollment,medications	72-96hrs post treatment
side effects of dexamethasone identified if any	elevation in glucose level, other symptoms associated with corticosteroids	72-96 hrs post treatment

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Study Director: Susan Watts, PhD., Texas Tech University Health Sciences Center, Department of Emergency Medicine; Study Director: Diluma Kariyawasam, MPH, Texas Tech University Health Sciences Center, El Paso

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dexamethasone; migraine headache; steroid treatment; peripheral nerve block
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Pregnadienetriols; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Dexamethasone; Calcium Dobesilate
• Other Study ID Numbers: E23081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No