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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Active Comparator | Patients receive an endoscopically guided injection of Exparel (Bupivacaine). |
|
| Saline | Placebo Comparator | Patients receive an endoscopically guided injection of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel (Bupivacaine Liposome) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Score | Scores range from 0-10 (0=no pain, 10=worst pain) | Baseline to day 21 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Hwang, MD | Contact | (650) 723-5281 | hwangph@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Hwang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter H Hwang | Recruiting | Stanford | California | 94304 | United States |
IPD will be kept confidential and private and won't be used for any other studies or shared with other researchers.
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| Saline | Drug | Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment |
|
| ID | Term |
|---|---|
| D005157 | Facial Pain |
| D008881 | Migraine Disorders |
| D003027 | Cluster Headache |
| D051303 | Trigeminal Autonomic Cephalalgias |
| D005156 | Facial Neuralgia |
| D051302 | Paroxysmal Hemicrania |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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