NCT05707754

Brief Summary

The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question\[s\] it aims to answer are:

  • Does a high dose (3ml) give more relief than a low dose (1ml)?
  • Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed. Researchers will compare dosage and administration to see how symptoms are reduced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

January 22, 2023

Last Update Submit

October 7, 2024

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

Low dose (1ml) with unilateral administration of bupivacaine

Drug: BupivacaineDevice: angiocatheter

Low dose with bilateral administration

ACTIVE COMPARATOR

Low dose (1ml) with bilateral administration of bupivacaine

Drug: BupivacaineDevice: angiocatheter

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

Introduced into nose to reach sphenopalatine ganglion nerve

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

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:

  • Allergy to bupivacaine
  • Nasal or sinus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

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)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Benjamin Friedman, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

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

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)