search
Back to results

Functional Endoscopic Sinus Surgery Study (FESS)

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1
Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient presenting for FESS
  • Patient consents to participate
  • No underlying chronic pain condition
  • No underlying bleeding diathesis

Exclusion Criteria:

  • Patient refuses to consent
  • Patient requires revision surgery
  • Patient requires surgery in addition to FESS
  • 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

Sites / Locations

  • UF Health of University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2019
Last Updated
May 26, 2023
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03970655
Brief Title
Functional Endoscopic Sinus Surgery Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1
Intervention Description
Group 1 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the LEFT pterygopalatine fossa
Intervention Type
Drug
Intervention Name(s)
Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2
Intervention Description
Group 2 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the RIGHT pterygopalatine fossa
Primary Outcome Measure Information:
Title
Change in Endoscopic Grading of Nasal Bleeding
Description
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.
Time Frame
Every 10 minutes up to 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy M Gunnett, RN, CCRC
Phone
352-273-8911
Email
AGunnett@anest.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Knudsen, MS
Phone
352-273-6786
Email
rknudsen@anest.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron R Smith
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health of University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Functional Endoscopic Sinus Surgery Study

We'll reach out to this number within 24 hrs