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

• Status: Not yet recruiting
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeffrey Alan Klein, MD
• Treatments: Epinephrine; Lidocaine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).