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

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Sphenopalatine Ganglion Neuralgia; Paroxysmal Hemicrania; Trigeminal Autonomic Cephalgia; Migraine; Craniofacial Pain; Cluster Headache

Treatments: Drug: Exparel (Bupivacaine Liposome); Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04930887

60832

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Exparel

Active Comparator group

Description:

Patients receive an endoscopically guided injection of Exparel (Bupivacaine).

Treatment:

Drug: Exparel (Bupivacaine Liposome)

Saline

Placebo Comparator group

Description:

Patients receive an endoscopically guided injection of saline

Treatment:

Drug: Saline