Lidocaine + Epinephrine for Local Anesthesia

Recruiting in Palo Alto (17 mi)

Overseen by Kira Minkis, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Weill Medical College of Cornell University

Must not be taking: MAOIs, Antidepressants

Disqualifiers: Pregnancy, Breastfeeding, Anesthetic allergy

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.

Will I have to stop taking my current medications?

If you are taking monoamine oxidase inhibitors (MAOI) or certain antidepressants like triptyline or imipramine, you cannot participate in the trial. For other medications, the protocol does not specify if you need to stop taking them.

What data supports the effectiveness of the drug Lidocaine + Epinephrine for local anesthesia?

Research shows that Lidocaine with Epinephrine is an effective local anesthetic for dental surgeries, like third molar extractions, and it does not cause significant adverse effects in healthy patients. ^{1 2 3 4 5}

Is Lidocaine with Epinephrine safe for use in humans?

Lidocaine with Epinephrine has been used safely in many outpatient surgeries and dermatologic procedures. Studies show it is generally safe, even in patients with heart disease, although caution is advised, especially in specific areas like fingers. There have been no reports of severe complications like digital gangrene with commercial preparations of Lidocaine with Epinephrine. ^{6 7 8 9 10}

How does the drug Lidocaine + Epinephrine differ from other treatments for local anesthesia?

Lidocaine + Epinephrine is unique because epinephrine prolongs the numbing effect of lidocaine by reducing blood flow, which enhances and extends the anesthetic effect. This combination is particularly useful in surgeries where both quick onset and prolonged anesthesia are needed, such as in eyelid surgeries. ^{11 12 13 14 15}

Research Team

Kira Minkis, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for individuals who require local anesthesia, possibly for dermatologic procedures. Specific eligibility criteria are not provided, so it's assumed that participants should be in good health and suitable for receiving local anesthetics.

Inclusion Criteria

I am 18 years old or older.

Ability to provide informed consent

Normal skin sensation at both nasal ala assessed by pinprick

Exclusion Criteria

Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated

Pregnant or breastfeeding volunteers (assessed by self-report)

I am currently taking MAOI or certain types of antidepressants.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive injections of lidocaine with epinephrine at different volumes on each side of the nasal ala. Sensation is tested every 15 minutes until return of sharp sensation.

Up to 4 hours

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and the effectiveness of the anesthetic post-treatment

1 week

Treatment Details

Interventions

• Lidocaine + Epinephrine (Local Anesthetic)

Trial Overview The study is testing the duration of pain relief from two different volumes of lidocaine mixed with epinephrine (0.5 ml and 1.0 ml) at sites with a lot of blood vessels to see if more anesthetic means longer pain relief.

Participant Groups

Group I: 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine Experimental Treatment 2 Interventions

Each side of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 1.0ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) and 0.5 ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala. Laterality of each anesthetic volume administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.

Group II: 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine Experimental Treatment 2 Interventions

Each side of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) and 1.0 ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala. Laterality of each anesthetic volume administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Weill Cornell Medicine New York, NY

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1103

Patients Recruited

1,157,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lidocaine with and without epinephrine on plasma epinephrine and lidocaine concentrations and hemodynamic values during third molar surgery. Meral, G., Tasar, F., Sayin, F., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an Additive to Local Anesthesia: A Step to Development in Dentistry. Singh, V., Thepra, M., Kirti, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of long-acting local anesthesia using etidocaine hydrochloride. Jensen, OT., Upton, LG., Hayward, JR., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of lidocaine with and without bupivacaine for local dental anesthesia. Oka, S., Shimamoto, C., Kyoda, N., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can local anesthesia with ropivacaine provide postoperative analgesia in extraction of impacted mandibular third molars? A randomized clinical trial. Amorim, KS., Gercina, AC., Ramiro, FMS., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Intradermal/Subcutaneous Lidocaine With Epinephrine Use in Dermatologic Surgery. Hirshburg, JM., Diven, DG., Edmiston, C., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive review of epinephrine in the finger: to do or not to do. Denkler, K.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of local anesthetic toxicity by vasoconstrictors. Taylor, SE., Dorris, RL.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is clonidine an adequate alternative to epinephrine as a vasoconstrictor in patients with hypertension? Patil, PM., Patil, SP.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of perioperative safety of local anesthesia with lidocaine containing epinephrine in patients with ischemic heart disease. Sanatkar, M., Sadeghi, M., Esmaeili, N., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. Yang, JJ., Zheng, J., Liu, HJ., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Comparative Study of the Pain of Local Anesthesia Using 2% Lidocaine, 2% Lidocaine With Epinephrine, and 2% Lidocaine With Epinephrine-Bupivicaine Mixture for Eyelid Surgery. Han, JW., Nah, SK., Lee, SY., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the mechanism by which epinephrine potentiates lidocaine's peripheral nerve block. Sinnott, CJ., Cogswell III, LP., Johnson, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of epinephrine on lidocaine pharmacokinetics and blood volume in the dental pulp. Hashimoto, S., Yamashiro, M., Fujita, K., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined use of local anesthetic with clonidine in cases of tooth extraction]. Mishunin, IuV., Ostreĭkov, IF., Nazarov, NA., et al.[2013]

References

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

Effects of lidocaine with and without epinephrine on plasma epinephrine and lidocaine concentrations and hemodynamic values during third molar surgery. [2013]

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

Dexmedetomidine as an Additive to Local Anesthesia: A Step to Development in Dentistry. [2022]

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

Advantages of long-acting local anesthesia using etidocaine hydrochloride. [2013]

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

Comparison of lidocaine with and without bupivacaine for local dental anesthesia. [2018]

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

Can local anesthesia with ropivacaine provide postoperative analgesia in extraction of impacted mandibular third molars? A randomized clinical trial. [2021]

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

Safety of Intradermal/Subcutaneous Lidocaine With Epinephrine Use in Dermatologic Surgery. [2021]

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

A comprehensive review of epinephrine in the finger: to do or not to do. [2019]

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

Modification of local anesthetic toxicity by vasoconstrictors. [2018]

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

Is clonidine an adequate alternative to epinephrine as a vasoconstrictor in patients with hypertension? [2013]

10. Iran pubmed.ncbi.nlm.nih.gov

The evaluation of perioperative safety of local anesthesia with lidocaine containing epinephrine in patients with ischemic heart disease. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. [2013]

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

A Prospective, Comparative Study of the Pain of Local Anesthesia Using 2% Lidocaine, 2% Lidocaine With Epinephrine, and 2% Lidocaine With Epinephrine-Bupivicaine Mixture for Eyelid Surgery. [2018]

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

On the mechanism by which epinephrine potentiates lidocaine's peripheral nerve block. [2022]

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

Effects of epinephrine on lidocaine pharmacokinetics and blood volume in the dental pulp. [2014]

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

[Combined use of local anesthetic with clonidine in cases of tooth extraction]. [2013]