Trials Sponsors Conditions Drugs Pricing

Conditions

Sphenopalatine Ganglion Nerve Block

Keywords

Sphenopalatine ganglion nervePeripheral nerve blockHeadacheMigraine

Outcome Measures

Primary Outcomes (1)

Number of participants demonstrating sustained headache relief
A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined
48 hours

Secondary Outcomes (1)

Number of participants demonstrating satisfaction with the procedure/medication
48 hours

Other Outcomes (1)

Number of participants demonstrating improvement in 0-10 pain scale
60 minutes

Study Arms (4)

High dose with unilateral administration

ACTIVE COMPARATOR

High dose (3ml) with unilateral administration of bupivacaine

Drug: BupivacaineDevice: angiocatheter

High dose with bilateral administration

ACTIVE COMPARATOR

High dose (3ml) with bilateral administration of bupivacaine

Drug: BupivacaineDevice: angiocatheter

Low dose with unilateral administration

ACTIVE COMPARATOR

Interventions

BupivacaineDrug

Topically applied to sphenopalatine ganglion

High dose with bilateral administrationHigh dose with unilateral administrationLow dose with bilateral administrationLow dose with unilateral administration

angiocatheterDevice

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Present to ED for management of headache
Headache is moderate or severe in intensity

You may not qualify if:

Sponsors & Collaborators

Montefiore Medical Center
Otherlead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

MeSH Terms

Conditions

HeadacheMigraine Disorders

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides

Study Officials

Benjamin Friedman, MD
Montefiore Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

220 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 1, 2023

Study Start

March 6, 2023

Actual (reported)

Sphenopalatine Ganglion Block Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (4)

High dose with unilateral administration

High dose with bilateral administration

Low dose with unilateral administration

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Low dose with bilateral administration

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (4)

High dose with unilateral administration

High dose with bilateral administration

Low dose with unilateral administration

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Low dose with bilateral administration

Data Sharing

Source record

Locations