Injection of Bupivacaine and Epinephrine for Sinus Surgery
Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
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 |
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | St. Paul's Hospital, Canada Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06456255 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 years or older who are scheduled for primary endoscopic sinus surgery.
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.
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 performed: Previous studies have shown mixed results regarding the effectiveness of similar interventions, making this approach somewhat novel.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia
- St.Paul's Hospital Sinus Center — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Amin Javer
- Email: sinusdoc@me.com
- Phone: 6048069926
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.