Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
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
Stanford University
15 participants
Feb 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria6
- 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
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Interventions
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
Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04930887