Bupivacaine and Epinephrine Injection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensorcaine with Epinephrine, Sham injection.
- Who it may be relevant to
- Registry conditions: Sinus Disease, Anesthesia, Bleeding. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
Overview
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.
Interventions
- Drug 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. - Other Sham injection
Punctures without any medication injected onto the septum
Primary outcome measures
- Boezzart bleeding score [Time frame: throughout study completion, one day study visit]
Secondary outcome measures (5)
- Total blood loss [Time frame: throughout study completion, one day study visit]
- Surgical time [Time frame: throughout study completion, one day study visit]
- Mean arterial pressure (MAP) [Time frame: throughout study completion, one day study visit]
- Postoperative bleeding [Time frame: throughout study completion, one day study visit]
- Postoperative pain [Time frame: throughout study completion, one day study visit]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St.Paul's Hospital Sinus Center — Vancouver
Identifiers
NCT: NCT06456255 · H24-01167