Anesthesia, Bleeding, Sinus Disease
Conditions
Keywords
endoscopic sinus surgery, bupivacaine, epinephrine
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 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
DRUGSensorcaine with Epinephrine
The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.
OTHERSham injection
Punctures without any medication injected onto the septum
Sponsors
Amin Javer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
We propose a double-blind, parallel arm, randomized controlled trial evaluating whether injecting 0.25% bupivacaine with 1:200,000 epinephrine is superior to no injection (sham procedure) during ESS.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boezzart bleeding score | throughout study completion, one day study visit | Change in mean surgical field quality as determined by the Boezzart bleeding score. Boezaart score of 0 indicates no bleeding, whereas the maximum score of 5 indicates severe bleeding (constant suctioning required). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | throughout study completion, one day study visit | Change in total blood between injection and sham group measured in millilitres |
| Surgical time | throughout study completion, one day study visit | Change in surgical time between injection and sham group measure in minutes |
| Mean arterial pressure (MAP) | throughout study completion, one day study visit | Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg) |
| Postoperative bleeding | throughout study completion, one day study visit | Change in postoperative bleeding between injection and sham group measured in mililiters |
| Postoperative pain | throughout study completion, one day study visit | Change in postoperative pain between injection and sham group measured with a Visual Analog Scale (VAS) grading from 0 (no pain) to 5 (severe pain) |
Countries
Canada
Contacts
Primary ContactAmin Javer
Outcome results
None listed