Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
220 participants
INTERVENTIONAL
2023-03-06
2024-08-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High dose with unilateral administration
High dose (3ml) with unilateral administration of bupivacaine
Bupivacaine
Topically applied to sphenopalatine ganglion
angiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
High dose with bilateral administration
High dose (3ml) with bilateral administration of bupivacaine
Bupivacaine
Topically applied to sphenopalatine ganglion
angiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
Low dose with unilateral administration
Low dose (1ml) with unilateral administration of bupivacaine
Bupivacaine
Topically applied to sphenopalatine ganglion
angiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
Low dose with bilateral administration
Low dose (1ml) with bilateral administration of bupivacaine
Bupivacaine
Topically applied to sphenopalatine ganglion
angiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
Interventions
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Bupivacaine
Topically applied to sphenopalatine ganglion
angiocatheter
Introduced into nose to reach sphenopalatine ganglion nerve
Eligibility Criteria
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Inclusion Criteria
* Headache is moderate or severe in intensity
Exclusion Criteria
* Nasal or sinus surgery
18 Years
ALL
Yes
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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Other Identifiers
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2022-14616
Identifier Type: -
Identifier Source: org_study_id
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