March 24, 2015

Nasal Bupivacaine Block of Sphenopalatine Ganglion Reduces Chronic Migraines

By Frances Morin

NATIONAL HARBOR, Md -- March 24, 2015 -- A nasal formulation of 0.5% bupivacaine effectively and safely reduces the frequency of headaches in patients with chronic migraine and reduces the average amount of pain associated with the headaches, according to a study presented here at the 31st Annual Meeting of the American Academy of Pain Medicine (AAPM).

“These data suggest long-term benefits using repetitive sphenopalatine ganglion (SPG) blocks utilising 0.5% bupivacaine delivered through a Tx360 device,” wrote Ryan Cady, MD, Banyan Group Inc., Springfield, Missouri, and colleagues in their presentation.

The SPG is a structure of neuronal tissue that is implicated in various orofacial pain conditions, including migraine. In order to determine the effects of the new nasal applicator design in blocking the SPG, the researchers randomised 41 patients per protocol, including 10 males and 31 females with a mean age of 41.30 and a diagnosis of International Classification of Headache Disorders (ICHD) -II definition of chronic migraine.

Patients had an average chronic migraine diagnosis of 8.58 years and on average experienced 15.24 migraines and 23.63 headaches in a month during baseline.

Among 38 patients who were ultimately analysed for the study, 26 were treated with bupivacaine (0.3 cc of 0.5% bupivacaine injected through a tube directed to the mucosa covering the SPG), and 12 received saline treatments, repeated twice daily for 6 weeks.

The results showed that patients receiving bupivacaine had a reduction in the number of headache days compared with baseline at the end of treatment and 1 month post-treatment (P = .001), according to daily headache diaries patients were instructed to complete at baseline and during and after the treatment period.

Patients receiving the saline showed no significant changes.

The bupivacaine group also had improvements in various other factors, including average pain (P = .001), general activity interference (P = .05), mood (P = .02), and the ability to accomplish normal work related tasks (P = .004).

The saline group meanwhile reported only slight reductions in average pain (P = .31), general activity interference (P = .53), and showed increased impairment in their mood (P = .38).

Patients in the bupivacaine group also had significant decreased Headache Impact Scores (HIT; -4.52; P = .005) from baseline to the end of the treatment period, compared with no significant change for the saline group (-1.50; P = .13).

HIT-6 scores were also significantly reduced among patients treated with bupivacaine at 1 month post-treatment (-5.13; P = .005) and 6 months post-treatment (-4.78; P = .003), compared with only slight improvements in the saline group.

There were no significant differences in adverse events reported between the groups.

“Benefits [from the nasal therapy] include a significant reduction in the number of headache days for subjects treating with bupivacaine,” the authors wrote. “Furthermore, subjects reported an overall reduction in average pain ratings and improvements in general activity levels, mood, and increased function at work over the treatment period and during the 6-month follow-up.”

Funding for this study was provided by Tian Medical.

[Presentation title: Long-Term Efficacy of Repetitive Sphenopalatine Blockade With Bupivacaine Versus Saline With the Tx360 Device for Treatment of Chronic Migraine. Abstract 104]
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