Endoscopic injection of Exparel for craniofacial pain relief
Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
This study is testing if an injection of Exparel can help people with craniofacial pain, like migraines and cluster headaches, feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04930887 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of endoscopically guided injection of Exparel (Bupivacaine) for treating craniofacial pain, including conditions like migraines and cluster headaches. The study employs a prospective, randomized, double-blinded, placebo-controlled, and cross-over design to assess the impact of Exparel on pain relief and functional outcomes. Participants will receive either the active treatment or a saline placebo, with the aim of determining if Exparel can provide significant pain relief compared to standard topical Lidocaine. The trial is designed to gather robust data on the efficacy of this novel approach to pain management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a chief complaint of craniofacial pain who have visited the Stanford Pain & ENT clinic.
Not a fit: Patients outside the age range of 18 to 80, pregnant women, or those with allergies to bupivacaine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from various forms of craniofacial pain.
How similar studies have performed: While the use of Exparel for pain relief is established, this specific application for craniofacial pain is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain \& ENT clinic visit Exclusion Criteria: * age \<18 or \>80 * pregnant women * economically disadvantaged (not able to afford clinic visits/treatments) * decisionally impaired (unable to obtain informed consent) * has allergy to bupivacaine * unable or unwilling to participate plans to participate in another clinical study at any time during this study
Where this trial is running
Stanford, California
- Peter H Hwang — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Peter Hwang, MD — Stanford University
- Study coordinator: Peter Hwang, MD
- Email: hwangph@stanford.edu
- Phone: (650) 723-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.