Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.

Official Title
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Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Conditions
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Intraoperative Bleeding

Intervention / Treatment
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* Drug: Epinephrin
* Drug: 1% lidocaine with epinephrin 1:100,000
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery Exclusion Criteria: Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2) Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis Patients with underlying uncontrolled hypertension Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery Patients who are allergic to adrenaline or to xylocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic sinus surgery<br>Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS). | Drug: Epinephrin<br>* Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity<br>* Other names: Adrenaline;Drug: 1% lidocaine with epinephrin 1:100,000<br>* 4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)<br>Drug: Saline<br>* 4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Field Grading Score | The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly). | postoperatively (approximately 20 minutes to assess) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery |  | intraoperatively (up to 3 hours) | 
| Number of Extra Pledgets Used | A pledget is a small wad of absorbent material used to stop bleeding. | intraoperatively (up to 3 hours) | 
| Estimated Blood Loss During Surgery |  | intraoperatively (up to 3 hours) | 
| Postoperative Bloody Discharge Grading Score | Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care). | 1 week after the surgery (up to 2 minutes to complete assessment) | 
| Number of Days With Postoperative Bloody Nasal Discharge | Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. | 1 week after the surgery (up to 2 minutes to complete assessment) | 
| Number of Nostrils With Continuous Fresh Bleeding | Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes. | 1 week after the surgery (up to 2 minutes to complete assessment) |