About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
age <18 or >80
pregnant women
economically disadvantaged (not able to afford clinic visits/treatments)
decisionally impaired (unable to obtain informed consent)
Trial design
Crossover
Treatments tested in this trial
Exparel (Bupivacaine Liposome)
DrugNon-opioid postsurgical analgesic used in the management of postsurgical pain; 133 mg/10 mL (13.3 mg/mL) single-dose vial (per Pacira), study administers 3cc bilaterally
Saline
DrugPrescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
Treatment groups
Trial outcomes
Primary outcomes
Change of Pain Score
Scores range from 0-10 (0=no pain, 10=worst pain)
Secondary outcomes
Change of Associated Symptoms
Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores
Sponsors and contacts
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