drugset / Trial / NCT06456255

Bupivacaine and Epinephrine Injection Study

NCT06456255

Phase 2/3 Recruiting 80 enrolled Amin Javer
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2024-11-15
Primary completion
2025-05
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 2.5 mg/ml
Subject Epinephrine Other / unclassified 5 ug/ml