NCT04930887PHASE2Recruiting

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

Stanford University

Start Date

2/1/2023

Completion Date

6/1/2030

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

Age Range: 18 years to 80 years

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

Interventions

DRUG

Exparel (Bupivacaine Liposome)

DRUG

Saline

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Conditions

Craniofacial PainMigraineCluster HeadacheTrigeminal Autonomic CephalgiaSphenopalatine Ganglion NeuralgiaParoxysmal Hemicrania

Locations

Peter H Hwang

Stanford, California 94304

United States