Actively Recruiting
Endoscopically Guided Injection of Exparel (Bupivacaine) for Craniofacial Pain: Prospective, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Trial
Led by Stanford University · Updated on 2026-04-27
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a chief complaint of craniofacial pain including migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglion neuralgia, or paroxysmal hemicrania
- Patients who have had a Stanford Pain & ENT clinic visit
- Age between 18 and 80 years
You will not qualify if you...
- Younger than 18 or older than 80 years
- Pregnant women
- Economically disadvantaged and unable to afford clinic visits or treatments
- Unable to provide informed consent due to decision-making impairment
- Allergy to bupivacaine
- Unable or unwilling to participate or plans to join another clinical study during this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days per treatment period
Participants receive endoscopically guided injections of Exparel (Bupivacaine) and saline in a crossover design to manage craniofacial pain.
2 injection visits and follow-up visits through Day 21 for each treatment period
Trial Site Locations
Total: 1 location
1
Peter H Hwang
Stanford, California, United States, 94304
Actively Recruiting
Research Team
P
Peter Hwang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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