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Completed

NCT Number: NCT05867342

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

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.

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Key information

Conditions

Intraoperative Bleeding Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrin

Drug

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

Other names: Adrenaline

1% lidocaine with epinephrin 1:100,000

Drug

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

Saline

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Duration of Surgery

    Time frame: intraoperatively (up to 3 hours)

  2. 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.

  3. Estimated Blood Loss During Surgery

    Time frame: intraoperatively (up to 3 hours)

  4. 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).

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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