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Functional Endoscopic Sinus Surgery Study

Functional Endoscopic Sinus Surgery Study

Recruiting
18-90 years
All
Phase 1/2

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Overview

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).

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.

Eligibility

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 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 study team, makes the patient a poor candidate for block placement.
  8. Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
  9. Vulnerable patient population

Study details
    Chronic Rhinosinusitis (Diagnosis)

NCT03970655

University of Florida

10 June 2024

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