Functional Endoscopic Sinus Surgery Study

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

— FESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03970655
• Other study ID #: IRB201900782
• Secondary ID: OCR21462
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 25, 2019
• Est. completion date: December 15, 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Cameron R Smith, MD
• Phone: 352-273-8651
• Email: csmith[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Rhinosinusitis

Intervention

Drug:
• Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1
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
Group 2 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the RIGHT pterygopalatine fossa

Locations

Country	Name	City	State
United States	UF Health of University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endoscopic Grading of Nasal Bleeding	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.	Every 10 minutes up to 36 hours