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RECRUITING
NCT06456255
PHASE2/PHASE3

Bupivacaine and Epinephrine Injection Study

Sponsor: Amin Javer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-11-15

Completion Date

2025-07

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

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

Locations (1)

St.Paul's Hospital Sinus Center

Vancouver, British Columbia, Canada