Injection of Bupivacaine and Epinephrine for Sinus Surgery
Official title: Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
Run by St. Paul's Hospital, Canada · NCT06456255 · Data updated 2026-11-12
This study is testing if injecting a mix of bupivacaine and epinephrine during sinus surgery can help doctors see better and reduce bleeding compared to a fake injection.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | St. Paul's Hospital, Canada Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | May 2025 |
| Study ends | July 2025 |
| Registry record updated | May 15, 2025 |
| Trial ID | NCT06456255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 years or older who are scheduled for primary endoscopic sinus surgery.
✕Probably not a fit
Patients with conditions such as cystic fibrosis, bleeding disorders, or those who have had previous sinus surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of injecting a combination of bupivacaine and epinephrine during endoscopic sinus surgery (ESS) to determine if it improves surgical visualization compared to a sham injection. The study aims to assess whether this intervention can reduce bleeding and enhance the surgeon's ability to perform the procedure effectively. Participants will be adults scheduled for primary ESS, and the outcomes will be compared between those receiving the active injection and those receiving a placebo.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications during endoscopic sinus surgery.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of similar interventions, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19 years or older * Scheduled for primary ESS (including septoplasty) Exclusion Criteria: * 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)
Where it's running
-
St.Paul's Hospital Sinus Center
Vancouver, British Columbia, Canada Recruiting
Study contacts
- Study coordinator: Amin Javer
- Email: sinusdoc@me.com
- Phone: 6048069926
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.