Status:
UNKNOWN
Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons
Lead Sponsor:
Jeffrey Alan Klein, MD
Conditions:
Venomous Snakebites
Local Anesthesia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief 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 c...
Detailed Description
The primary aim of this research is to demonstrate that of subcutaneous injection of tumescent (dilute) lidocaine and epinephrine (TLE) is safe, well tolerated, and easily performed by nearly anyone w...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04733781
Start Date
February 22 2021
End Date
June 7 2021
Last Update
February 8 2021
Active Locations (1)
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1
HK Dermatology Care Center
San Juan Capistrano, California, United States, 92675