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

Anesthesia Bleeding Sinus Disease

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

Inclusion Criteria2

Age 19 years or older
Scheduled for primary ESS (including septoplasty)

Exclusion Criteria9

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)