NCT04930887 Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
| NCT ID | NCT04930887 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Craniofacial Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2023-02-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).
Eligibility 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
Contact & Investigator
Peter Hwang, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04930887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Craniofacial Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04930887 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04930887 currently recruiting?
Yes, NCT04930887 is actively recruiting participants. Contact the research team at hwangph@stanford.edu for enrollment information.
Where is the NCT04930887 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04930887 clinical trial?
NCT04930887 is sponsored by Stanford University. The principal investigator is Peter Hwang, MD at Stanford University. The trial plans to enroll 15 participants.