What is this study investigating for sinus disease?

This study is examining whether injecting a local anesthetic and vasoconstrictor during endoscopic sinus surgery improves the surgeon's ability to see compared to no injection. The research aims to better understand how to reduce bleeding and improve surgical conditions. The study is led by Amin Javer and focuses on treatment techniques.

Who may be eligible for this sinus disease clinical trial?

Adults aged 19 years or older who are scheduled for their first endoscopic sinus surgery including septoplasty may be eligible. People with cystic fibrosis, bleeding disorders, previous sinus surgery, or recent inhaled drug use may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this sinus disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 19Years +

All Genders

ID06456255

Effect of Bupivacaine and Epinephrine Injection Compared to No Injection During Endoscopic Sinus Surgery to Improve Surgical Visualization

Led by Amin Javer · Updated on 2025-05-15

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Endoscopic sinus surgery ESS is a common procedure to clear sinus cavities, remove inflamed tissue, and enhance sinus medication use. This trial evaluates whether injecting a combination of local anesthetic and vasoconstrictor during ESS improves the surgeons view compared to no injection. Previous studies indicated saline injections may have similar effects, so this study aims to clarify the benefit of the drug combination during surgery. Participants are randomly assigned to one of two groups one receives an injection of 0.25% bupivacaine with epinephrine, and the other undergoes a sham injection involving only a puncture without medication. The trial is double-blinded, so neither participants nor surgeons know which procedure is given. The study takes place during the one-day surgery visit. During the procedure, researchers assess bleeding using the Boezzart bleeding score along with total blood loss, surgical time, blood pressure, postoperative bleeding, and pain. These measures are recorded throughout the surgery day. The study aims to enroll adults aged 19 and older scheduled for primary ESS, with follow-up focused on surgical conditions and recovery outcomes.

CONDITIONS

Brief Title

Bupivacaine and Epinephrine Injection Study

Who Can Participate

Age: 19Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 19 years or older
Scheduled for primary endoscopic sinus surgery including septoplasty

You will not qualify if you...

Cystic fibrosis
Systemic vasculitis or any bleeding disorders
Known or suspected hypersensitivity to bupivacaine or epinephrine
Previous sinus surgery
Inhaled drug use (e.g., cocaine) in the past 6 months
Nasal tumors
Patients taking antiarrhythmic medications
History of severe liver illness
High-risk patient for complications based on anesthesiologist assessment (e.g., untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism, or diabetes)

Research Team

Amin Javer

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