A Phase 1 interventional study of Bupivacaine and angiocatheter in Sphenopalatine Ganglion Nerve Block, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Montefiore Medical Center · Phase 1, Interventional, and Treatment
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:
Researchers will compare dosage and administration to see how symptoms are reduced.
1,235 studies on the registry are indexed under Headache; 201 are open to participants now.
This study's enrollment of 220 is above the median of 60 across 926 interventional studies indexed under Headache.
Browse Headache studies →Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.
Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
High dose (3ml) with unilateral administration of bupivacaine
Drug: Bupivacaine · Device: angiocatheter
High dose (3ml) with bilateral administration of bupivacaine
Drug: Bupivacaine · Device: angiocatheter
Low dose (1ml) with unilateral administration of bupivacaine
Drug: Bupivacaine · Device: angiocatheter
Low dose (1ml) with bilateral administration of bupivacaine
Drug: Bupivacaine · Device: angiocatheter
Topically applied to sphenopalatine ganglion
Introduced into nose to reach sphenopalatine ganglion nerve
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
Time frame: 48 hours
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?"
Time frame: 48 hours
Number of participants demonstrating improvement in 0-10 pain scale
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine