FESS: Functional Endoscopic Sinus Surgery Study

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03970655

Collaborator

(none)

Enrollment

Location

Arms

43.6

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis (Diagnosis)	Drug: Bupivacaine with epinephrine plus dexamethasone - Group 1 Drug: Bupivacaine with epinephrine plus dexamethasone - Group 2	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 25, 2019

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine 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 without epinephrine with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side)	Drug: Bupivacaine with epinephrine plus dexamethasone - Group 1 Group 1 will receive 4 ml of 0.5% Bupivacaine with epinephrine in the LEFT pterygopalatine fossa
Experimental: Group 2 a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine 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 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).	Drug: Bupivacaine with epinephrine plus dexamethasone - Group 2 Group 2 will receive 4 ml of 0.5% Bupivacaine with epinephrine in the RIGHT pterygopalatine fossa

Arm

Intervention/Treatment

Experimental: Group 1

a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine 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 without epinephrine with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side)

Drug: Bupivacaine with epinephrine plus dexamethasone - Group 1

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

Experimental: Group 2

a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine 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 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).

Drug: Bupivacaine with epinephrine plus dexamethasone - Group 2

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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