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Completed

NCT Number: NCT03970655

Functional Endoscopic Sinus Surgery Study

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UF Health of University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient presenting for bilateral FESS
  • Adult patients (>18 and < 90 years old)
  • Patient consents to participate
  • No underlying chronic pain condition
  • No underlying bleeding diathesis

Exclusion criteria

  • Patient refuses to consent
  • Patient requires revision or unilateral surgery
  • Patient requires surgery in addition to FESS
  • Age younger than 18 or older than 90 years
  • Any underlying chronic pain condition
  • History of bleeding diathesis
  • 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.
  • 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.
  • Vulnerable patient population

Treatment and study plan

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1

Drug

Group 1 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the LEFT pterygopalatine fossa

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2

Drug

Group 2 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the RIGHT pterygopalatine fossa

Primary outcomes

  1. Change in Endoscopic Grading of Nasal Bleeding

    Time frame: Every 10 minutes up to 36 hours

    Endoscopic Grading of Nasal Bleeding will be calculated using the 0-5 point Boezaart surgical field grading scale; 0 being no bleeding and 5 being severe bleeding.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study

Acronym: FESS

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 31, 2019
Registry last updated
Jul 30, 2026

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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