Clinical trial NCT03970655: Functional Endoscopic Sinus Surgery Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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 criteria: 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

Primary outcomes:
measure: Change in Endoscopic Grading of Nasal Bleeding
timeFrame: Every 10 minutes up to 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health of University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Cameron R Smith
role: PRINCIPAL_INVESTIGATOR
References: