Your session is about to expire
← Back to Search
Local Anesthetic
Epinephrine-enhanced Anesthesia for Chronic Sinusitis (FESS Trial)
Phase 1 & 2
Recruiting
Led By Cameron Smith
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No underlying chronic pain condition
Patient presenting for bilateral FESS
Must not have
Patient requires revision or unilateral surgery
Patient requires surgery in addition to FESS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 10 minutes up to 36 hours
Awards & highlights
Summary
This trial will test whether adding epinephrine to a standard sinus surgery procedure can reduce intraoperative bleeding and blood loss.
Who is the study for?
This trial is for adults aged 18 to 90 who are having bilateral functional endoscopic sinus surgery (FESS) for chronic sinusitis and don't have a history of chronic pain or bleeding disorders. Candidates must consent to participate and not require additional surgeries beyond FESS.
What is being tested?
The study tests the effect of adding epinephrine to anesthetic blocks on blood loss during FESS. There are two groups, both receiving bupivacaine or ropivacaine with epinephrine plus dexamethasone, but possibly differing in concentration or volume.
What are the potential side effects?
Possible side effects may include localized numbness, discomfort at injection site, increased heart rate due to epinephrine, allergic reactions, and rare complications related to nerve blocks like bleeding or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a chronic pain condition.
Select...
I am scheduled for sinus surgery on both sides of my face.
Select...
I am between 18 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need surgery to correct or replace a previous procedure or on one side of my body.
Select...
I need surgery beyond sinus surgery.
Select...
I am either younger than 18 or older than 90 years old.
Select...
I have a long-term pain condition.
Select...
I do not agree to participate in this study.
Select...
I have a history of unusual bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 10 minutes up to 36 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 10 minutes up to 36 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Endoscopic Grading of Nasal Bleeding
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
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).
Group II: Group 1Experimental Treatment1 Intervention
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)
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,315 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
Cameron SmithPrincipal InvestigatorUniversity of Florida
Cameron R SmithPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a chronic pain condition.I have a long-term pain condition.I need surgery to correct or replace a previous procedure or on one side of my body.I need surgery beyond sinus surgery.You do not have a condition that makes you prone to bleeding.I am either younger than 18 or older than 90 years old.People who are at a higher risk of harm or exploitation.I am scheduled for sinus surgery on both sides of my face.I am between 18 and 90 years old.I do not agree to participate in this study.I have a history of unusual bleeding.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 1
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger