Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2024-11-15
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Injection
\- Injection 0.25% bupivacaine with 1:200,000 epinephrine
Sensorcaine with Epinephrine
The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.
Sham injection
\- Sham injection (only puncture, no injecting anything)
Sham injection
Punctures without any medication injected onto the septum
Interventions
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Sensorcaine with Epinephrine
The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.
Sham injection
Punctures without any medication injected onto the septum
Eligibility Criteria
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Inclusion Criteria
* Scheduled for primary ESS (including septoplasty)
Exclusion Criteria
* 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)
19 Years
ALL
No
Sponsors
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Amin Javer
OTHER
Responsible Party
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Amin Javer
Clinical Professor
Locations
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St.Paul's Hospital Sinus Center
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Other Identifiers
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H24-01167
Identifier Type: -
Identifier Source: org_study_id
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