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

June 16, 2023 updated by: Peter Hwang, Stanford University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Adrenaline
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Field Grading Score
Time Frame: postoperatively (approximately 20 minutes to assess)
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
Time Frame: intraoperatively (up to 3 hours)
intraoperatively (up to 3 hours)
Number of Extra Pledgets Used
Time Frame: intraoperatively (up to 3 hours)
A pledget is a small wad of absorbent material used to stop bleeding.
intraoperatively (up to 3 hours)
Estimated Blood Loss During Surgery
Time Frame: intraoperatively (up to 3 hours)
intraoperatively (up to 3 hours)
Postoperative Bloody Discharge Grading Score
Time Frame: 1 week after the surgery (up to 2 minutes to complete assessment)
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
Time Frame: 1 week after the surgery (up to 2 minutes to complete assessment)
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
Time Frame: 1 week after the surgery (up to 2 minutes to complete assessment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Peter H Hwang, MD, Stanford University
  • Principal Investigator: Navarat Tangbumrungtham, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2017

Primary Completion (Actual)

August 22, 2018

Study Completion (Actual)

August 22, 2018

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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