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

Study Overview
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Brief Summary
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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).

Official Title
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Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain

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

Intervention / Treatment
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* Drug: Exparel (Bupivacaine Liposome)
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exparel<br>Patients receive an endoscopically guided injection of Exparel (Bupivacaine). | Drug: Exparel (Bupivacaine Liposome)<br>* Non-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<br>|
| Placebo Comparator: Saline<br>Patients receive an endoscopically guided injection of saline | Drug: Saline<br>* Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Score | Scores range from 0-10 (0=no pain, 10=worst pain) | Baseline to day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to day 21 |