Evaluating the effect of epinephrine on bleeding during sinus surgery
Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study
This study is testing if adding epinephrine to a specific type of pain relief can help reduce bleeding during sinus surgery for people with chronic sinus problems.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT03970655 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of adding epinephrine to ultrasound-guided pterygopalatine ganglion blocks on intra-operative bleeding during functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis. FESS is a common procedure for patients with chronic sinus issues, and minimizing surgical bleeding is crucial for safety and efficiency. The study will be randomized, double-blinded, and controlled, comparing the effects of two different anesthetic combinations with epinephrine on blood loss and surgical time. The goal is to determine if this approach can enhance surgical outcomes by reducing complications associated with excessive bleeding.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who are scheduled for bilateral functional endoscopic sinus surgery.
Not a fit: Patients requiring revision or unilateral surgery, or those with chronic pain conditions or bleeding disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient sinus surgeries with reduced bleeding and complications.
How similar studies have performed: While the specific combination of epinephrine and ultrasound-guided blocks is novel, similar approaches to minimizing bleeding in surgical procedures have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- UF Health of University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Cameron R Smith — University of Florida
- Study coordinator: Cameron R Smith, MD
- Email: csmith@anest.ufl.edu
- Phone: 352-273-8651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.