UF Health of University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT03970655
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).
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Notify Me18 year–90 year
All sexes
Interventional
Phase 1 / Phase 2
Gainesville, Florida, 32610, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group 1 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the LEFT pterygopalatine fossa
Group 2 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the RIGHT pterygopalatine fossa
Time frame: 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.
University of Florida
Other
Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study
Acronym: FESS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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