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

Primary Purpose

Migraine

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Oral
Placebo
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine headache, peripheral nerve block, dexamethasone, steroid treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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% 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

Sites / Locations

  • University Medical Center of El PasoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

single oral dose of dexamethasone (8mg)

Single oral dose of placebo pill

Outcomes

Primary Outcome Measures

Recurrence of headache
Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred

Secondary Outcome Measures

Early recurrence headache and timing
HA severity, location, time since enrollment enrollment,medications
side effects of dexamethasone identified if any
elevation in glucose level, other symptoms associated with corticosteroids

Full Information

First Posted
August 21, 2023
Last Updated
September 26, 2023
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT06016465
Brief Title
Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?
Official Title
Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine headache, peripheral nerve block, dexamethasone, steroid treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 for study drug vs placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
single oral dose of dexamethasone (8mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single oral dose of placebo pill
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral
Other Intervention Name(s)
Decadron
Intervention Description
Two 4mg pills
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dextrose methyl cellulose
Intervention Description
2 placebo pills
Primary Outcome Measure Information:
Title
Recurrence of headache
Description
Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred
Time Frame
72-96 hours post treatment
Secondary Outcome Measure Information:
Title
Early recurrence headache and timing
Description
HA severity, location, time since enrollment enrollment,medications
Time Frame
72-96hrs post treatment
Title
side effects of dexamethasone identified if any
Description
elevation in glucose level, other symptoms associated with corticosteroids
Time Frame
72-96 hrs post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Michelson, MD
Phone
915 215 4600
Email
edward.michelson@ttuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Watts, PhD.
Organizational Affiliation
Texas Tech University Health Sciences Center, Department of Emergency Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center of El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leann Rodriguez
Phone
915-215-4976
Email
rod72863@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Edward A Michelson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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