NCT06456255

Bupivacaine and Epinephrine Injection Study

Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Amin Javer · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinus Disease
• Anesthesia
• Bleeding

Interventions

Type	Name	Description
DRUG	Sensorcaine with Epinephrine	The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.
OTHER	Sham injection	Punctures without any medication injected onto the septum

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2024-06-13
• Last updated: 2025-05-15

Locations

1 site across 1 country: Canada