Bupivacaine and Epinephrine Injection Study
Recruiting
Phase 2
Phase 3
Interventional Study
Sinus Disease
Anesthesia
Bleeding
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Amin Javer · Other
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About This Trial
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 19 years or older
* Scheduled for primary ESS (including septoplasty)
Exclusion Criteria:
* Cystic fibrosis
* Systemic vasculitis or any bleeding disorders
* Known or suspected hypersensitivity to bupivacaine or epinephrine
* Previous sinus surgery
* Inhaled drug use (i.…
Contacts