Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endoscopic sinus surgery 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
Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity
Other Names:
Drug: 1% lidocaine with epinephrin 1:100,000
4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)
Drug: Saline
4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
|
Outcome Measures
Primary Outcome Measures
- Surgical field grading score [Up to 30 minutes to assess]
The video recording of the endoscopic sinus surgery of the participant will be graded by another otolaryngology specialist and will be graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly).
Secondary Outcome Measures
- Postoperative bloody discharge grading score [1 week after the surgery (up to 2 minutes to complete assessment)]
Grading of postoperative bloody discharge assessed by patient using the postoperative bleeding questionaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care).
- Number of days with postoperative bloody nasal discharge [1 week after the surgery (up to 2 minutes to complete assessment)]
Days with postoperative bloody nasal discharge assessed by patient using the postoperative bleeding questionaire.
- Number of patients with excessive fresh bleeding [1 week after the surgery (up to 2 minutes to complete assessment)]
Assessed by patient using the postoperative bleeding questionaire.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford | Stanford | California | United States | 94304 |
Sponsors and Collaborators
- Stanford University
Investigators
- Study Director: Peter H Hwang, MD, Stanford University
- Principal Investigator: Navarat Tangbumrungtham, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1275-81. doi: 10.1097/MLG.0b013e31816dd2d9.
- Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
- Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.
- Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11.
- Yang JJ, Li WY, Jil Q, Wang ZY, Sun J, Wang QP, Li ZQ, Xu JG. Local anesthesia for functional endoscopic sinus surgery employing small volumes of epinephrine-containing solutions of lidocaine produces profound hypotension. Acta Anaesthesiol Scand. 2005 Nov;49(10):1471-6. doi: 10.1111/j.1399-6576.2005.00869.x.
- Yang JJ, Zheng J, Liu HJ, Liu YX, Shen JC, Zhou ZQ. Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. J Pharm Pharm Sci. 2006;9(2):190-7.
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