The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Indiana University
Indianapolis, Indiana, United States
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
Time frame: 15 minutes from dose
Categorical Pain Relief
Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided.
Time frame: 15 minutes from dose
Headache Free at 24 Hours
The percentage of patients that were headache free at 24 hours by follow-up phone conversation.
Time frame: 24 hours
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