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Completed

NCT Number: NCT05707754

Sphenopalatine Ganglion Block Study

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.

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Key information

Conditions

Sphenopalatine Ganglion Nerve Block Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Topically applied to sphenopalatine ganglion

angiocatheter

Device

Introduced into nose to reach sphenopalatine ganglion nerve

Primary outcomes

  1. Number of participants demonstrating sustained headache relief

    Time frame: 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 outcomes

  1. Number of participants demonstrating satisfaction with the procedure/medication

    Time frame: 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?"

Other outcomes

  1. Number of participants demonstrating improvement in 0-10 pain scale

    Time frame: 60 minutes

    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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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