Long‐Term Efficacy of a Double‐Blind, Placebo‐Controlled, Randomized Study for Repetitive Sphenopalatine Blockade With Bupivacaine vs Saline With the Tx360^® Device for Treatment of Chronic Migraine

Abstract

Background.-This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360 ® device results in long-term improvement in chronic migraine (CM). The SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve. In a previous article, these authors reported repetitive SPG blockades with 0.5% bupivacaine delivered by the Tx360 ® device, which was an effective and well-tolerated intervention to incrementally decrease baseline headache intensity of subjects with CM.Methods.-This was a double-blind, parallel-arm, placebo-controlled, randomized pilot study using a novel intervention for acute treatment in CM. A total of 41 subjects were enrolled at two headache specialty clinics in the USA. Eligible subjects were between 18 and 80 years of age and had a history of CM defined by International Classification of Headache Disorders-II definition. Subjects were allowed a stable dose of migraine preventive medications that was maintained throughout the study.

Invasive pericranial nerve interventions

“…In a recent randomized, double-blind, placebocontrolled trial, repetitive 0.5% bupivacaine blockades of the sphenopalatine ganglion with the Tx360 Õ device twice a week for 6 weeks were compared to saline injections in chronic migraine patients (26). Slight but non-significant reductions in headache days and average pain scores were found in the bupivacaine group.…”

A Narrative Review of Evidence-Based Preventive Options for Chronic Migraine

“…Sphenopalatine ganglion blockade in the treatment of chronic migraine has been evaluated in a double-blind, placebo-controlled, randomized study of 41 subjects (bupivacaine, n=26 versus saline, n=12) that demonstrated that 0.5 % bupivacaine delivered via a noninvasive device twice a week for 6 weeks was superior to saline with a statistically significant difference in the numerical pain score at 15 min, 30 min, and 24 h after the procedure [29]. Endpoints for longer term efficacy, however, such as the number of headache days 1 month posttreatment, did not meet statistical significance in this small study [30]. Larger randomized, controlled trials of nerve blocks are necessary to further define the efficacy of these treatments.…”

Diagnosis and Treatment of Primary Headache Disorders in Older Adults

“…Lidocaine and bupivacaine are typically used in greater occipital nerve blocks for migraine or TTH and occipital neuralgia, whereas methylprednisolone acetate is typically used for cluster headache . Sphenopalatine nerve block with topical anesthetics can be effective when used consistently for acute treatment or prevention of chronic migraine . Nerve blocks are a particularly good choice when there is a need to limit the systemic effects of oral medications.…”