Functional Endoscopic Sinus Surgery Study

Last updated: April 29, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

1/2

Condition

Sinusitis

Rhinitis, Allergic, Perennial

Sinus Infections

Treatment

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1

Clinical Study ID

NCT03970655
IRB201900782
OCR21462
  • Ages 18-90
  • All Genders

Study Summary

The aim of this study is to evaluate the effect of the addition of epinephrine to bilateral real time ultrasound guided pterygopalatine ganglion blocks on intra-operative bleeding and blood loss during functional endoscopic sinus surgery (FESS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient presenting for bilateral FESS

  2. Adult patients (>18 and < 90 years old)

  3. Patient consents to participate

  4. No underlying chronic pain condition

  5. No underlying bleeding diathesis

Exclusion

Exclusion Criteria:

  1. Patient refuses to consent

  2. Patient requires revision or unilateral surgery

  3. Patient requires surgery in addition to FESS

  4. Age younger than 18 or older than 90 years

  5. Any underlying chronic pain condition

  6. History of bleeding diathesis

  7. Presence of any other factor which, at the discretion of any member of the studyteam, makes the patient a poor candidate for block placement.

  8. Presence of any other factor which, at the discretion of any member of the studyteam, makes the patient a poor candidate for research participation.

  9. Vulnerable patient population

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2
Phase: 1/2
Study Start date:
September 25, 2019
Estimated Completion Date:
December 15, 2026

Study Description

FESS is the treatment of choice in patients with medically refractory chronic rhinosinusitis and chronic polypous rhinosinusitis. This surgery relies on minimal surgical site bleeding to be performed efficiently and safely. Hemorrhage during FESS decreases visibility of the surgical field and this increases the risk of vascular, orbital and intracranial complications as well as procedural failure. Thus the importance of minimizing surgical bleeding in this procedure. The maxillary artery is the primary blood supply for the sinuses and midface. Conceptually the application of epinephrine into the pterygopalatine fossa onto the maxillary artery with the block should result in constriction of this artery and subsequently, less bleeding from the surgical site. This randomized, double-blinded, controlled pilot study will investigate the utility of addition of epinephrine to bilateral pterygopalatine ganglion blocks performed under ultrasound guidance in minimizing surgical site bleeding and overall blood loss and the potential for shortening the surgical time.

Connect with a study center

  • UF Health of University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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