Epinephrine-enhanced Anesthesia for Chronic Sinusitis
(FESS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Florida
Disqualifiers: Chronic pain, Bleeding diathesis, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
36789How 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.
110111213Eligibility Criteria
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.
+2 more
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.
+6 more
Trial Timeline
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
Participant Groups
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.
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)
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
πͺπΊ Approved in European Union as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
π¨π¦ Approved in Canada as Sensorcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UF Health of University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
[Combined anaesthesia for rhinoseptoplasty in pediatric patients]. [2013]The article deals with efficiency and advantages analysis of Marcaine 0.25% and Epinephrine 1:200000 intraoperative uses as a supplementary analgesia for rhinoseptoplasty in Pediatric patients.
Effect of perioperative administration of ropivacaine with epinephrine on postoperative pediatric adenotonsillectomy recovery. [2018]To determine whether perioperative administration of ropivacaine hydrochloride with epinephrine decreases postoperative pain following adenotonsillectomy and to determine the pharmacokinetics of ropivacaine following injection.
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]Bupivacaine (Marcaine), homologue of mepivacaine, chemically related to lidocaine, is used as a local anesthetic for local infiltration, peripheral nerve block, retrobulbar block, symphathetic block, and caudal and epidural anesthesia. The aim of this investigation was to determine and to compare clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor.
In children, the addition of epinephrine modifies the pharmacokinetics of ropivacaine injected caudally. [2018]To describe the modification of the ropivacaine (R) pharmacokinetics produced by the addition of epinephrine (E).
The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. [2022]To compare the administration of bupivacaine hydrochloride, dexamethasone and lidocaine hydrochloride in decreasing post-tonsillectomy pain.
[The use of Marcaine in obstetrical analgesia]. [2013]Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]Two forms of 0.5% bupivacaine hydrochloride, Anecaine (Pliva) (n = 15) and Marcaine (Astra) (n = 15) were used for epidural anesthesia. The clinical picture of conduction block induced by the two local anesthetics varied. It manifested by a shorter latent period of analgesia development at the level of catheter and the drug infusion (LII) and relatively delayed development of analgesia in peripheral zones for Anecaine in comparison with marcaine. The authors conclude that solutions of local anesthetics containing the same active agent in the same concentrations under different commercial names manufactured by different companies may be characterized by different clinical picture of conduction blockade.
Ropivacaine. [2022]Ropivacaine (Naropin, AstraZeneca) is a long-acting amide local anaesthetic released for clinical use in 1996. Similar to bupivacaine, ropivacaine is equally effective for s.c. infiltration, epidural and peripheral nerve block for surgery, obstetric and post-operative analgesia. Ropivacaine differs from most other amide-type local anaesthetics in that it is marketed as a pure S-enantiomer, instead of as a racemate. This feature improves the safety of ropivacaine, and, indeed, studies have shown ropivacaine to have less cardiovascular and CNS toxicity than bupivacaine. Ropivacaine is nearly identical to bupivacaine in onset, quality and duration of sensory block, but it produces less motor block. Whether or not the motor sparing effect of ropivacaine is due to a lower relative potency compared to bupivacaine is a matter of intense debate. Despite a better safety profile, the increased cost of ropivacaine may limit its clinical utility.
Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. [2022]The ideal local anesthetic agent for facial plastic surgery should have rapid onset, good surgical anesthesia, and reasonably long duration. The purpose of this prospective, randomized, double-blind study was to compare 1% lidocaine hydrochloride with 1:200,000 epinephrine with 0.5% bupivacaine hydrochloride with 1:200,000 epinephrine, a newer, longer-acting local anesthetic, in different facial operations. The results suggest that bupivacaine is an effective and safe agent for these procedures.
Epinephrine Affects Pharmacokinetics of Ropivacaine Infiltrated Into Palate. [2018]Pulpal anesthesia success rates for ropivacaine following maxillary infiltration anesthesia seem to be low. We investigated the hypothesis that the addition of epinephrine would affect the pharmacokinetics of ropivacaine by retaining ropivacaine in the mucosa of the injected area through the time-dependent distribution of ropivacaine in the rat maxilla and serum following maxillary infiltration anesthesia using (3)H-labeled ropivacaine. We then examined the vasoactivity of ropivacaine with or without epinephrine on local peripheral blood flow. The addition of epinephrine to ropivacaine increased ropivacaine concentrations in the palatal mucosa and adjacent maxilla by more than 3 times that of plain ropivacaine at 20 minutes. By observing the autoradiogram of (3)H-ropivacaine, plain ropivacaine in the maxilla was remarkably reduced 20 minutes after injection. However, it was definitely retained in the palatal mucosa, hard palate, adjacent maxilla, and maxillary nerve after the administration with epinephrine. Ropivacaine with epinephrine significantly decreased labial blood flow. This study suggests that 10 ΞΌg/mL epinephrine added to 0.5% ropivacaine could improve anesthetic efficacy and duration for maxillary infiltration anesthesia over plain ropivacaine.
Vasoconstriction and analgesic efficacy of locally infiltrated levobupivacaine for nasal surgery. [2018]In this study, we compared the use of preincisional lidocaine 2% with epinephrine (LA) and levobupivacaine 0.25% plain (LB) for postoperative analgesia and vasoconstriction in patients undergoing nasal surgery.
Effect of increasing amounts of epinephrine during isobaric bupivacaine spinal anesthesia in elderly patients. [2013]The effects of adding epinephrine to isobaric bupivacaine spinal anesthesia were investigated in 96 ASA class II-III patients aged 75 yr or more scheduled for lower extremity surgery. The subjects were randomly allocated into six groups. All patients received 15 mg bupivacaine plain solution in 4 ml, in the horizontal position. Patients in group 1 received bupivacaine plus 1 ml normal saline; patients in other groups received bupivacaine plus increasing dosages of epinephrine: 0.1 mg (group 2), 0.2 mg (group 3), 0.3 mg (group 4), 0.4 mg (group 5), 0.5 mg (group 6). The segmental level of sensory loss was tested using forceps. The time required for maximal spread of the sensory blockade was significantly 50% greater in group 5 than in group 1. No difference was observed, however, between mean highest levels. Addition of 0.2 mg epinephrine prolonged by a significant 25% regression time to L-2 level. Addition of 0.3 and 0.4 mg epinephrine significantly prolonged two-segment regression time by 36 and 53%, respectively, and regression to L-2 level by 29 and 44%, respectively. Addition of 0.5 mg epinephrine did not result in further prolongation of anesthesia. Motor blockade was also increased by addition of epinephrine. It is concluded that addition of 0.3 mg epinephrine may be useful to increase duration of isobaric bupivacaine spinal anesthesia.
The effects of epinephrine on the anesthetic and hemodynamic properties of ropivacaine and bupivacaine after epidural administration in the dog. [2018]Ropivacaine is a new local anesthetic that is chemically related to mepivacaine and bupivacaine. Previous laboratory studies have demonstrated that ropivacaine possesses an anesthetic profile similar to that of bupivacaine and has less arrhythmogenic potential. The current study was initiated to compare the hemodynamic and anesthetic effects of epidurally administered 0.75% bupivacaine and 1% ropivacaine, with and without epinephrine (1:200,000), in the dog. Two groups of six dogs were randomly assigned to the ropivacaine or bupivacaine treatment groups. Administration of 0.75% bupivacaine and 1% ropivacaine with and without epinephrine was randomized. Volumes of 3 ml of each solution were injected in a blinded manner via an indwelling lumbar epidural catheter with 48 hours between injections. No statistically significant difference existed between the four treatment groups with regard to onset and duration of sensory or motor block. Hemodynamic changes were, for the most part, not different between drugs. Significant decreases were seen in mean arterial blood pressure and cardiac output in all test groups. No difference in the degree of cardiovascular depression was observed. The addition of epinephrine did not alter onset or duration of sensory or motor block in this animal model. Epinephrine reduced the average anesthetic blood concentration observed in both treatment groups at the various time intervals, but not the time to achieve the mean maximum blood level. No residual adverse effects were observed in any animal.