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New treatment option for Sinus Disease
Official title Bupivacaine and Epinephrine Injection Study
ClinicalTrials.gov ID: NCT06456255
What this study is testing
What is Sensorcaine with Epinephrine?
Sensorcaine with Epinephrine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for sinus disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
You likely can't join if
- 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
See the full eligibility criteria
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.