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

Sponsor

Texas Tech University Health Sciences Center, El Paso (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06016465

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized 1:1 for study drug vs placeboRandomized 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?

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Sep 10, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%