Chronic Rhinosinusitis (Diagnosis)
Conditions
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.
Interventions
DRUGBupivacaine 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
DRUGBupivacaine 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
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCameron R Smith
University of Florida
Outcome results
None listed