Functional Endoscopic Sinus Surgery Study

Phase 1

Recruiting

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1; Drug: Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2

• Registration Number: NCT03970655
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Study Start: 2019-09-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1	a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine with epinephrine 1:200.000 with the addition of 4 milligrams of dexamethasone (1ml) and a single injection into the RIGHT pterygopalatine fossa fo 4 milliliters of 0.5% Bupivacaine or Ropivacaine without epinephrine with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side)
Group 2	Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2	a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine without epinephrine with the addition of 4 milligrams of dexamethasone (1ml) and a single injection into the RIGHT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine with epinephrine 1:200.00 with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side).

Primary Outcome Measures

Name	Time	Method
Change in Endoscopic Grading of Nasal Bleeding	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.

Trial Locations

Locations (1)

UF Health of University of Florida; 🇺🇸 Gainesville, Florida, United States