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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 10 minutes up to 36 hours

Awards & highlights

FESS Trial 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.Check my eligibility

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.See study design

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.

FESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have a chronic pain condition.

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I am scheduled for sinus surgery on both sides of my face.

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I am between 18 and 90 years old.

FESS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Endoscopic Grading of Nasal Bleeding

FESS 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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,587 Total Patients Enrolled

1 Trials studying Chronic Sinusitis

Cameron SmithPrincipal InvestigatorUniversity of Florida

Cameron R SmithPrincipal InvestigatorUniversity of Florida

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03970655 — Phase 1 & 2

Chronic Sinusitis Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT03970655 — Phase 1 & 2

Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03970655 — Phase 1 & 2

Chronic Sinusitis Research Study Groups: Group 2, Group 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional investigations that have focused on the effects of Bupivacaine combined with epinephrine and dexamethasone - Group 2?

"Currently, there are 670 ongoing clinical trials examining the efficacy of Bupivacaine with epinephrine plus dexamethasone - Group 2. Of these studies, 165 have reached Phase 3 trials, and many of them take place in Joliet, Illinois. Across the entire United States, 18700 sites are running investigations into this medication."

Answered by AI

What is the current enrollment of participants in this trial?

"True, according to clinicaltrials.gov, this research is currently recruiting participants. The study was first made available on September 25th 2019 and has since been updated as recently as July 6th 2022. A total of 40 people are sought for involvement at a single medical centre."

Answered by AI

What demographic is eligible to partake in this medical experiment?

"This clinical trial is in search of 40 individuals who, between 18 and 90 years old, are currently suffering from a chronic illness. Additionally, suitable participants must not have an existing chronic pain condition, give their consent to take part and be free from any underlying bleeding disorders."

Answered by AI

Are seniors above the age of sixty permissible to participate in this laboratory study?

"This medical trial has an age range of 18-90 years old as a prerequisite for inclusion. 102 studies are available to younger patients, while 693 trials have been made accessible to those over 65."

Answered by AI

Is this research initiative currently accepting participants?

"Affirmative. According to the clinicaltrials.gov database, recruitment for this experiment is currently active; it was first posted on September 25th 2019 and most recently edited on July 6th 2022. The study requires 40 participants from a single site."

Answered by AI

What medical applications does Bupivacaine with epinephrine plus dexamethasone - Group 2 usually address?

"Group 2 of Bupivacaine with epinephrine and dexamethasone is prescribed to treat ophthalmia, sympathetic. It has also been used clinically in cases of branch retinal vein occlusion, laryngotracheobronchitis, and macular edema."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Functional Endoscopic Sinus Surgery Study

2019. "Functional Endoscopic Sinus Surgery Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970655.

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