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

Early Phase 1

Recruiting

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Dexamethasone Oral

• Registration Number: NCT06016465
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

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.

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 Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-29
• Study Start: 2023-09-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single oral dose of placebo pill
Dexamethasone	Dexamethasone Oral	single oral dose of dexamethasone (8mg)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University Medical Center of El Paso; 🇺🇸 EL Paso, Texas, United States