Sphenopalatine Ganglion Block Study

Phase 1

Completed

• Conditions: Sphenopalatine Ganglion Nerve Block
• Interventions: Drug: Bupivacaine; Device: angiocatheter

• Registration Number: NCT05707754
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-22
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-02-01
• Study Start: 2023-03-06
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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Exclusion Criteria

• Allergy to bupivacaine
• Nasal or sinus surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose with unilateral administration	Bupivacaine	Low dose (1ml) with unilateral administration of bupivacaine
Low dose with bilateral administration	Bupivacaine	Low dose (1ml) with bilateral administration of bupivacaine
Low dose with unilateral administration	angiocatheter	Low dose (1ml) with unilateral administration of bupivacaine
High dose with unilateral administration	Bupivacaine	High dose (3ml) with unilateral administration of bupivacaine
High dose with unilateral administration	angiocatheter	High dose (3ml) with unilateral administration of bupivacaine
High dose with bilateral administration	angiocatheter	High dose (3ml) with bilateral administration of bupivacaine
Low dose with bilateral administration	angiocatheter	Low dose (1ml) with bilateral administration of bupivacaine
High dose with bilateral administration	Bupivacaine	High dose (3ml) with bilateral administration of bupivacaine

Primary Outcome Measures

Name	Time	Method
Number of participants demonstrating sustained headache relief	48 hours	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

Name	Time	Method
Number of participants demonstrating satisfaction with the procedure/medication	48 hours	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?"

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States