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Bupivacaine and Epinephrine Injection Study

RecruitingPhase 2, Phase 3Ages 19 Years - anyAllAmin Javer
NCT06456255 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Sensorcaine with Epinephrine
  • Sham injection
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Where

1 site
St.Paul's Hospital Sinus Center
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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