Sphenopalatine Ganglion Nerve Block
Conditions
Keywords
Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine
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.
Interventions
DRUGBupivacaine
Topically applied to sphenopalatine ganglion
DEVICEangiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants demonstrating improvement in 0-10 pain scale | 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 |
Countries
United States
Outcome results
None listed