Volume 15 Supplement 1
EHMTI-0268. Long term efficacy of repetitive sphenopalatine blockade with bupivacaine vs. Saline with the tx360 device for treatment of chronic migraine
© Cady et al; licensee Springer. 2014
Published: 18 September 2014
The sphenopalatine ganglion (SPG) resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and has been implicated in orofacial pain conditions including migraine. Blocking the SPG using local anesthetics may relieve pain associated with chronic migraine.
The purpose of this study was to evaluate safety and efficacy following treatment with repetitive SPG blocks using 0.5% bupivacaine vs. saline.
This was an IRB approved, 2 center, randomized, double-blind, placebo controlled study with 41 consented adult subjects, meeting ICHD-II definition of chronic migraine. Subjects were randomized 2:1 following a 28 day baseline period and received either 0.3 mL of 0.5% bupivacaine (group A) or saline (group B) delivered to the mucosal surface of the SPG though each nares with the Tx360® device. The procedure was repeated twice weekly for 6 weeks with follow-up visits 1 and 6 months post treatment.
There was a 6-day reduction in headache days for group A (p=.001) vs. a 2-day reduction for group B at 6 months (p=.09). HIT-6 scores were lower at 6 months vs. baseline for group A (p=.03) but not for Group B (p=.59). Furthermore, subjects receiving bupivacaine reported less work interference (p=.004), mood interference (p=.02), general activity (p=.05) relative to baseline. There were no significant changes in these measures for the saline group.
These data suggest long-term benefits using repetitive SPG blockade with bupivacaine delivered by the Tx360® device. Benefits include a reduction of headache days and improvement in several quality of life assessments.
Conflict of interest.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.