Epinephrine-enhanced Anesthesia for Chronic Sinusitis

(FESS Trial)

Overseen By Cameron R Smith, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Florida

Disqualifiers: Chronic pain, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

Is epinephrine-enhanced anesthesia safe for humans?

Bupivacaine (Marcaine) and ropivacaine (Naropin) are generally safe when used as local anesthetics, with bupivacaine having minimal side effects when used correctly, and ropivacaine showing even less cardiovascular and central nervous system toxicity. Bupivacaine with epinephrine has been found to be safe in facial plastic surgery. ^{1 2 3 4 5}

How does the drug used in the Epinephrine-enhanced Anesthesia for Chronic Sinusitis trial differ from other treatments?

This treatment is unique because it combines bupivacaine or ropivacaine with epinephrine, which helps to prolong the anesthetic effect by keeping the drug in the targeted area longer and reducing blood flow. This combination may enhance the duration and effectiveness of anesthesia compared to using bupivacaine or ropivacaine alone. ^{6 7 8 9 10}

What data supports the effectiveness of the drug Epinephrine-enhanced Anesthesia for Chronic Sinusitis?

Research shows that combining epinephrine with anesthetics like bupivacaine and ropivacaine can enhance pain relief and improve recovery in surgeries, such as rhinoseptoplasty and adenotonsillectomy, suggesting potential benefits for chronic sinusitis treatment. ^{2 7 11 12 13}

Who Is on the Research Team?

Cameron Smith, MD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I do not have a chronic pain condition.

Patient consents to participate

You do not have a condition that makes you prone to bleeding.

Exclusion Criteria

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.

I have a long-term pain condition.

I need surgery to correct or replace a previous procedure or on one side of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bilateral ultrasound guided pterygopalatine ganglion blocks with or without epinephrine during functional endoscopic sinus surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including endoscopic grading of nasal bleeding

36 hours

Continuous monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Dexamethasone
• Epinephrine
• Ropivacaine

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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)

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

The study evaluates the effectiveness and benefits of using Marcaine 0.25% combined with Epinephrine 1:200,000 as a supplementary pain relief method during rhinoseptoplasty in children.

This analysis focuses on pediatric patients, highlighting the potential for improved pain management and reduced need for additional analgesics during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined anaesthesia for rhinoseptoplasty in pediatric patients]. Mayorov, VM., Akolzina, IL., Batueva, VA., et al.[2013]

In a study involving 130 children aged 2 to 12 undergoing adenotonsillectomy, the administration of 0.5% ropivacaine with epinephrine did not significantly reduce postoperative pain compared to a placebo, with pain scores favoring the placebo group.

The use of ropivacaine was associated with higher rates of retching in the recovery room (41% vs 19% for placebo), indicating potential adverse effects, and it is not recommended for postoperative analgesia in this pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of perioperative administration of ropivacaine with epinephrine on postoperative pediatric adenotonsillectomy recovery. Park, AH., Pappas, AL., Fluder, E., et al.[2018]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

The addition of epinephrine to ropivacaine significantly lowers the maximum concentration of ropivacaine in the bloodstream and delays the time it takes to reach this peak concentration, indicating altered absorption rates.

Epinephrine also slows the absorption rate of ropivacaine, which could enhance the duration of its effects when used in caudal blocks for anesthesia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In children, the addition of epinephrine modifies the pharmacokinetics of ropivacaine injected caudally. Van Obbergh, LJ., Roelants, FA., Veyckemans, F., et al.[2018]

In a study of 80 children aged 6 to 14 undergoing tonsillectomy, bupivacaine, dexamethasone, and lidocaine significantly reduced postoperative pain compared to a placebo on the first day after surgery.

Lidocaine was found to be more effective than bupivacaine in reducing pain on the third postoperative day, suggesting it may be the preferred option for managing pain in the days following tonsillectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. Kaygusuz, I., Susaman, N.[2022]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Ropivacaine, a long-acting local anesthetic, is safer than bupivacaine, showing less cardiovascular and central nervous system toxicity, making it a preferable option for various types of anesthesia.

While ropivacaine provides similar sensory block effects as bupivacaine, it causes less motor block, which may be beneficial in certain surgical situations, although its higher cost could limit its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine. Owen, MD., Dean, LS.[2022]

In a randomized, double-blind study comparing 1% lidocaine with epinephrine to 0.5% bupivacaine with epinephrine for facial plastic surgery, bupivacaine demonstrated effective and safe anesthesia.

Bupivacaine, being a longer-acting local anesthetic, may provide better surgical conditions compared to lidocaine, making it a suitable choice for facial procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. Maimon, WN., Schuller, DE.[2022]

The addition of epinephrine to ropivacaine significantly increases the concentration of the anesthetic in the palatal mucosa and adjacent maxilla, enhancing its effectiveness for maxillary infiltration anesthesia.

Ropivacaine combined with epinephrine not only improves anesthetic efficacy but also reduces local blood flow, which may help prolong the duration of anesthesia compared to using ropivacaine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epinephrine Affects Pharmacokinetics of Ropivacaine Infiltrated Into Palate. Yamashiro, M., Hashimoto, S., Yasuda, A., et al.[2018]

In a study of 60 patients undergoing nasal surgery, levobupivacaine 0.25% provided significantly better and longer-lasting postoperative pain relief compared to lidocaine 2% with epinephrine, as indicated by lower pain scores at multiple time points post-surgery.

Patients receiving levobupivacaine also required less rescue analgesic treatment in the first 24 hours after surgery, highlighting its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasoconstriction and analgesic efficacy of locally infiltrated levobupivacaine for nasal surgery. Demiraran, Y., Ozturk, O., Guclu, E., et al.[2018]

In a study of 96 elderly patients undergoing lower extremity surgery, adding 0.3 mg of epinephrine to bupivacaine significantly prolonged the duration of spinal anesthesia, enhancing the regression time to the L-2 level by 29%.

The addition of epinephrine also increased the motor blockade, indicating that it can effectively enhance the anesthetic effects of bupivacaine without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of increasing amounts of epinephrine during isobaric bupivacaine spinal anesthesia in elderly patients. Racle, JP., Benkhadra, A., Poy, JY., et al.[2013]

Ropivacaine and bupivacaine showed similar hemodynamic and anesthetic effects in a study involving 12 dogs, with no significant differences in the onset or duration of sensory or motor block.

The addition of epinephrine did not affect the anesthetic effects but reduced the average blood concentration of the anesthetics without causing any residual adverse effects in the animals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of epinephrine on the anesthetic and hemodynamic properties of ropivacaine and bupivacaine after epidural administration in the dog. Hurley, RJ., Feldman, HS., Latka, C., et al.[2018]

Citations

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Combined anaesthesia for rhinoseptoplasty in pediatric patients]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of perioperative administration of ropivacaine with epinephrine on postoperative pediatric adenotonsillectomy recovery. [2018]

3. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

In children, the addition of epinephrine modifies the pharmacokinetics of ropivacaine injected caudally. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Ropivacaine. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Epinephrine Affects Pharmacokinetics of Ropivacaine Infiltrated Into Palate. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Vasoconstriction and analgesic efficacy of locally infiltrated levobupivacaine for nasal surgery. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Effect of increasing amounts of epinephrine during isobaric bupivacaine spinal anesthesia in elderly patients. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

The effects of epinephrine on the anesthetic and hemodynamic properties of ropivacaine and bupivacaine after epidural administration in the dog. [2018]