A Novel Revision to the Classical Transnasal Topical Sphenopalatine Ganglion Block for the Treatment of Headache and Facial Pain

Abstract

Background: The sphenopalatine ganglion (SPG) is located with some degree of variability near the tail or posterior aspect of the middle nasal turbinate. The SPG has been implicated as a strategic target in the treatment of various headache and facial pain conditions, some of which are featured in this manuscript. Interventions for blocking the SPG range from minimally to highly invasive procedures often associated with great cost and unfavorable risk profiles. Objective: The purpose of this pilot study was to present a novel, FDA-cleared medication delivery device, the Tx360® nasal applicator, incorporating a transnasal needleless topical approach for SPG blocks. This study features the technical aspects of this new device and presents some limited clinical experience observed in a small series of head and face pain cases. Study Design: Case series. Settings: Pain management center, part of teaching-community hospital, major metropolitan city, United States. Methods: After Institutional Review Board (IRB) approval, the technical aspects of this technique were examined on 3 patients presenting with various head and face pain conditions including trigeminal neuralgia (TN), chronic migraine headache (CM), and post-herpetic neuralgia (PHN). The subsequent response to treatment and quality of life was quantified using the following tools: the 11-point Numeric Rating Scale (NRS), Modified Brief Pain Inventory — short form (MBPI-sf), Patient Global Impression of Change (PGIC), and patient satisfaction surveys. The Tx360® nasal applicator was used to deliver 0.5 mL of ropivacaine 0.5% and 2 mg of dexamethasone for SPG block. Post-procedural assessments were repeated at 15 and 30 minutes, and on days one, 7, 14, and 21 with a final assessment at 28 days post-treatment. All patients were followed for one year. Individual patients received up to 10 SPG blocks, as clinically indicated, after the initial 28 days. Results: Three women, ages 43, 18, and 15, presented with a variety of headache and face pain disorders including TN, CM, and PHN. All patients reported significant pain relief within the first 15 minutes post-treatment. A high degree of pain relief was sustained throughout the 28 day follow-up period for 2 of the 3 study participants. All 3 patients reported a high degree of satisfaction with this procedure. One patient developed minimal bleeding from the nose immediately post-treatment which resolved spontaneously in less than 5 minutes. Longer term follow-up (up to one year) demonstrated that additional SPG blocks over time provided a higher degree and longer lasting pain relief. Limitations: Controlled double blind studies with a higher number of patients are needed to prove efficacy of this minimally invasive technique for SPG block. Conclusion: SPG block with the Tx360® is a rapid, safe, easy, and reliable technique to accurately deliver topical transnasal analgesics to the area of mucosa associated with the SPG. This intervention can be delivered in as little as 10 seconds with the novice provider developing proficiency very quickly. Further investigation is certainly warranted related to technique efficacy, especially studies comparing efficacy of Tx360 and standard cotton swab techniques. Key words: Trigeminal neuralgia, trigeminal neuropathy, migraine, headache, post-herpetic neuralgia, sphenopalatine ganglion block

Sphenopalatine ganglion block in primary headaches

“…It is notable that the Tx360 applicator has had 4 studies evaluating its efficacy in chronic migraine and its efficacy in the emergency department setting for treatment of anterior or global headaches. 2,3,6,8,9 These studies may offer some possible protocols for treatment, dosing, and scheduling of blocks. The Allevio and SphenoCath catheters have, thus far, not had any randomized trials evaluating their use as treatment delivery devices.…”

“…To date, only the Tx360 has had randomized trials evaluating its use as a treatment delivery device, with an unclear basis of how these protocols were developed. 2,3,[6][7][8][9] In addition, differences in efficacy and tolerability between the different applicators and traditional SPG-blocking techniques are unknown.…”

Pain relief in a patient with massive sino-nasal tumor

“…The SPG plays an important role in controlling various pain syndromes including different type of headaches, trigeminal and sphenopalatine neuralgia, atypical facial pain, muscle pain, vasomotor rhinitis, eye disorders, and post herpetic neuralgia. 5 A recent study demonstrated the role of SPGB in also relieving post-dural puncture headache (PDPH) syndrome. 6 Different approaches that can be adopted to block sphenopalatine ganglion include trans nasal, anterior rhinoscope guided, trans-zygomatic with image intensifier.…”

Transnasal Sphenopalatine Ganglion Block for the Preventive Treatment of Chronic Daily Headache in Adolescents

“…Located in the pterygopalatine fossa, the SPG is easily accessible through the nose below the middle turbinate [8]. SPG blocks have been performed for decades, using techniques of varying invasiveness and accuracy [9]. In recent years, a non-invasive medication delivery device called the Tx360 ® (Tian Medical Inc., Lombard, IL, USA) was developed specifically to access the SPG through the nose.…”

“…In recent years, a non-invasive medication delivery device called the Tx360 ® (Tian Medical Inc., Lombard, IL, USA) was developed specifically to access the SPG through the nose. The device allows for more patient comfort as compared to a cotton-tip swab, which has been used historically for transnasal SPG access [9]. In adults, repeat SPG blockade with bupivacaine delivered with the Tx360 ® device reduced number of headache days and improved quality of life in chronic migraine patients [8].…”