Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Venomous Snakebites, Local Anesthesia, Painless Injection, Regional Anesthesia, Dermatologic Surgery, Cutaneous Pain, Musculoskeletal Pain

In brief

This research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.

Key facts

Study ID

NCT04733781

Run by

Jeffrey Alan Klein, MD

People needed

36

Starts

2021-02-22

Expected to finish

2021-06-07

Last updated by the study team

2021-02-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All volunteer subjects will be healthy, mature in behavior and temperament, without mental impairment and at least 16 years of age.
• A volunteer TLE research subject must be a non-medical-professional layperson and must have signed an IRB-approved informed consent form prior to participation.
• All subjects must weigh at least 40kg = 88lb

You may not qualify if…

• Anyone who has a significant fear of needles or fear of injections
• A history of lidocaine allergy.
• A significant history of epinephrine hypersensitivity.
• History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope).
• Significant needle phobia or anxiety.
• Vasovagal reaction associated with any medical procedures or the sight of blood.
• Uncontrolled or labile hypertension.
• Hyperthyroidism, thyroid medications.
• Recent phenylephrine (Actifed®) or pseudoephedrine use.
• Any significant cardiac arrhythmia including controlled atrial fibrillation tachycardia, mitral valve prolapse.
• Significant chronic renal impairment.
• Significant liver function abnormalities.
• History of having or having had a blood born infection with HIV, Hepatitis B, Hepatitis C.
• Evidence of active skin infection.
• Pregnant women are excluded.
• Subject has recently taken any drug(s) known to interfere with the metabolism of lidocaine such as erythromycin, clarithromycin, ketoconazole, fluconazole, sertraline (Zoloft), or ciprofloxacin.
• Subject has recently taken any drug known to interact adversely with epinephrine such as pseudoephedrine, ephedrine, or beta-blocker.
• History of radiation therapy or surgery involving the area near the proposed injection site.
• Pre-existing or concurrent infections (cutaneous, urinary, pneumonia are exclusionary).

Where it is running

• HK Dermatology Care Center — San Juan Capistrano, California, United States

Full record on ClinicalTrials.gov

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