Status:
RECRUITING
Bupivacaine and Epinephrine Injection Study
Lead Sponsor:
Amin Javer
Conditions:
Sinus Disease
Anesthesia
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief 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 m...
Eligibility 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)
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06456255
Start Date
November 15 2024
End Date
July 1 2025
Last Update
May 15 2025
Active Locations (1)
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1
St.Paul's Hospital Sinus Center
Vancouver, British Columbia, Canada, V6Z 1Y6