RecruitingPhase 2

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

United States15 participantsStarted 2023-02-01

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change of Pain Score

Timeframe: Baseline to day 21

Trial details

NCT IDNCT04930887

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Peter Hwang, MD

(650) 723-5281 hwangph@stanford.edu

View on ClinicalTrials.gov More Craniofacial Pain trials