Functional Endoscopic Sinus Surgery Study

NCT ID: NCT03970655

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2027-01-23

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2

Intervention Type: DRUG

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

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 Type: EXPERIMENTAL

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cameron R Smith

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health of University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR21462

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201900782

Identifier Type: -

Identifier Source: org_study_id