Actively Recruiting
Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
Led by Amin Javer · Updated on 2025-05-15
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Bupivacaine and Epinephrine Injection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St.Paul's Hospital Sinus Center
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
A
Amin Javer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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