← 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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 10 minutes up to 36 hours for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 9Eligibility criteria met