Study of Endoscopically Guided Injection of Exparel Bupivacaine to Treat Craniofacial Pain A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial for Adults 18 to 80 Years

What this Trial Is About

Researchers are evaluating the effectiveness of an endoscopically guided injection of Exparel Bupivacaine for treating craniofacial pain conditions such as migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglion neuralgia, and paroxysmal hemicrania. This Phase 2 prospective, randomized, double-blinded, placebo-controlled, and crossover study aims to determine whether injecting Exparel into the lateral nasal wall can improve pain and functional outcomes in patients who respond to topical Lidocaine during ENT endoscopy. Participants receive either an injection of Exparel Bupivacaine Liposome, a non-opioid pain reliever, or a saline placebo through an endoscopic procedure targeting the ipsilateral pterygopalatine fossa. The study administers a single dose of 3cc bilaterally. The trial involves a crossover design where patients receive both treatments in different periods to compare effects. During the study, pain scores and associated symptoms will be monitored from baseline through day 21 to assess changes. Participants will attend clinic visits at the Stanford Pain & ENT Clinic, where their pain and functional outcomes will be evaluated. The total participation period includes assessments up to 21 days after treatment, with safety and symptom monitoring throughout. The study excludes pregnant women, those allergic to bupivacaine, and individuals unable to consent or participate fully.

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain