RecruitingPhase 2Phase 3NCT06456255

Bupivacaine and Epinephrine Injection Study

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


Sponsor

Amin Javer

Enrollment

80 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sensorcaine with Epinephrine and Sham injection for people with anesthesia, bleeding, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSensorcaine with Epinephrine

The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.

OTHERSham injection

Punctures without any medication injected onto the septum


Locations(1)

St.Paul's Hospital Sinus Center

Vancouver, British Columbia, Canada

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NCT06456255


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