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Sphenopalatine Ganglion Block Study

Primary Purpose

Sphenopalatine Ganglion Nerve Block

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
angiocatheter
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sphenopalatine Ganglion Nerve Block focused on measuring Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Present to ED for management of headache Headache is moderate or severe in intensity Exclusion Criteria: Allergy to bupivacaine Nasal or sinus surgery

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High dose with unilateral administration

High dose with bilateral administration

Low dose with unilateral administration

Low dose with bilateral administration

Arm Description

High dose (3ml) with unilateral administration of bupivacaine

High dose (3ml) with bilateral administration of bupivacaine

Low dose (1ml) with unilateral administration of bupivacaine

Low dose (1ml) with bilateral administration of bupivacaine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants demonstrating satisfaction with the procedure/medication
Satisfaction with the procedure/medication as evidenced by the number of participants who provide an affirmative response to the question "Do you want to receive the same procedure/medication the next time you come to the ER with migraine?"

Full Information

First Posted
January 22, 2023
Last Updated
July 28, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05707754
Brief Title
Sphenopalatine Ganglion Block Study
Official Title
A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sphenopalatine Ganglion Nerve Block
Keywords
Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose with unilateral administration
Arm Type
Active Comparator
Arm Description
High dose (3ml) with unilateral administration of bupivacaine
Arm Title
High dose with bilateral administration
Arm Type
Active Comparator
Arm Description
High dose (3ml) with bilateral administration of bupivacaine
Arm Title
Low dose with unilateral administration
Arm Type
Active Comparator
Arm Description
Low dose (1ml) with unilateral administration of bupivacaine
Arm Title
Low dose with bilateral administration
Arm Type
Active Comparator
Arm Description
Low dose (1ml) with bilateral administration of bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Topically applied to sphenopalatine ganglion
Intervention Type
Device
Intervention Name(s)
angiocatheter
Intervention Description
Introduced into nose to reach sphenopalatine ganglion nerve
Primary Outcome Measure Information:
Title
Number of participants demonstrating sustained headache relief
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of participants demonstrating satisfaction with the procedure/medication
Description
Satisfaction with the procedure/medication as evidenced by the number of participants who provide an affirmative response to the question "Do you want to receive the same procedure/medication the next time you come to the ER with migraine?"
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Number of participants demonstrating improvement in 0-10 pain scale
Description
Pain will be assessed using an 11-point numerical rating scale (NRS) as recommended for use in migraine research by the International Headache Society. The NRS scale asks subjects to assign their pain a number between 0 and 10, with 0 = no pain and 10 = worst pain imaginable. Pain scores will be ascertained prior to procedure and at one hour
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Present to ED for management of headache Headache is moderate or severe in intensity Exclusion Criteria: Allergy to bupivacaine Nasal or sinus surgery
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Phone
718-920-6626
Email
befriedm@montefiore.org
First Name & Middle Initial & Last Name & Degree
Dane McCarthy, PA
Email
damccarthy@montefiore.org

12. IPD Sharing Statement

Learn more about this trial

Sphenopalatine Ganglion Block Study

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