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

Stanford University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraoperative Bleeding

Interventions

EpinephrinDRUG

Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity

1% lidocaine with epinephrin 1:100,000DRUG

4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)

SalineDRUG

4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford

Stanford, California, United States

Outcomes

Primary Outcomes

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).

Time frame: postoperatively (approximately 20 minutes to assess)

Secondary Outcomes

Duration of Surgery

Time frame: intraoperatively (up to 3 hours)

Number of Extra Pledgets Used

A pledget is a small wad of absorbent material used to stop bleeding.

Time frame: intraoperatively (up to 3 hours)

Estimated Blood Loss During Surgery

Time frame: 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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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