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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection | Experimental | - Injection 0.25% bupivacaine with 1:200,000 epinephrine |
|
| Sham injection | Placebo Comparator | - Sham injection (only puncture, no injecting anything) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensorcaine with Epinephrine | Drug | The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate [(1:200,000) 5 mcg/mL] per vial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Boezzart bleeding score | 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). | throughout study completion, one day study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Total blood loss | Change in total blood between injection and sham group measured in millilitres | throughout study completion, one day study visit |
| Surgical time | Change in surgical time between injection and sham group measure in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amin Javer | Contact | 6048069926 | sinusdoc@me.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Paul's Hospital Sinus Center | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| ID | Term |
|---|---|
| D010254 | Paranasal Sinus Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
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| Sham injection | Other | Punctures without any medication injected onto the septum |
|
| throughout study completion, one day study visit |
| Mean arterial pressure (MAP) | Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg) | throughout study completion, one day study visit |
| Postoperative bleeding | Change in postoperative bleeding between injection and sham group measured in mililiters | throughout study completion, one day study visit |
| Postoperative pain | 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) | throughout study completion, one day study visit |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |