Bupivacaine and Epinephrine Injection Study
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Sinus Disease, Anesthesia, Bleeding
In brief
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 shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.
Key facts
- Study ID
- NCT06456255
- Run by
- Amin Javer
- People needed
- 80
- Starts
- 2024-11-15
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2025-05-15
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
You may not qualify if…
- Cystic fibrosis
- Systemic vasculitis or any bleeding disorders
- Known or suspected hypersensitivity to bupivacaine or epinephrine
- Previous sinus surgery
- Inhaled drug use (i.e., cocaine) in the preceding 6 months
- Nasal tumors
- Patients on antiarrhythmics.
- Patients with history of severe liver illness.
- Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)
Where it is running
- St.Paul's Hospital Sinus Center — Vancouver, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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