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

• ClinicalTrials.gov Identifier: NCT06016465
• Recruitment Status: Recruiting
• First Posted: August 29, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Information provided by (Responsible Party): Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso

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
Migraine	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: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized 1:1 for study drug vs placebo
• Masking: 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: Treatment
• Official Title: Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
• Actual Study Start Date: September 15, 2023
• Estimated Primary Completion Date: August 30, 2024
• Estimated Study Completion Date: September 10, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dexamethasone; single oral dose of dexamethasone (8mg)	Drug: Dexamethasone Oral; Two 4mg pills; Other Name: Decadron
Placebo Comparator: Placebo; Single oral dose of placebo pill	Drug: Placebo; 2 placebo pills; Other Name: Dextrose methyl cellulose

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Edward Michelson, MD; 915 215 4600; edward.michelson@ttuhsc.edu

Locations

United States, Texas

University Medical Center of El Paso; Recruiting

El Paso, Texas, United States, 79905

Contact: Leann Rodriguez 915-215-4976 rod72863@ttuhsc.edu

Principal Investigator: Edward A Michelson, MD

Sponsors and Collaborators

Texas Tech University Health Sciences Center, El Paso

Investigators

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

More Information

• Responsible Party: Edward Michelson, MD, Professor and Chair Dept of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso
• ClinicalTrials.gov Identifier: NCT06016465
• Other Study ID Numbers: E23081
• First Posted: August 29, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso:

migraine headache; peripheral nerve block; dexamethasone; steroid treatment

Additional relevant MeSH terms:

Recurrence; Headache; Disease Attributes; Pathologic Processes; Pain; Neurologic Manifestations; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents