A Phase 2/3 interventional study of Tumescent Lidocaine and Epinephrine in Venomous Snakebites, Local Anesthesia and Painless Injection, sponsored by Jeffrey Alan Klein, MD. Status unknown at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Jeffrey Alan Klein, MD · Phase 2/3, Interventional, and Treatment
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.
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 who is at least 16 years old. The primary aim will be achieved by conducting an IRB-approved double-blind, non-inferiority, randomized clinical trial (RCT).
The indications for TLE when injected into subcutaneous tissue are
The present TLE-RCT has three research Arms, which are as follows:
Injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I): A volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh.
Injection of 125ml by a physician and 125ml by another volunteer (Arm II): A volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional.
Injection of 250ml by a physician into a volunteer (Arm III) : A volunteer layperson (research subject), at least 16 years of age, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician.
There will be two TLE formulations, F1 and F2.
Individual subjects will be randomly assigned to receive either F1 or F2. The maximum dosage of tumescent lidocaine is 5mg/kg, which is clearly a safe dosage given that the risk of mild lidocaine toxicity at 28mg/kg of 0.1% TLE is 1 per 5,000,000
Exclusion Criteria:
A volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh.
Drug: Tumescent Lidocaine and Epinephrine
A volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional.
Drug: Tumescent Lidocaine and Epinephrine
A volunteer layperson (research subject), at least 16 years old, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician.
Drug: Tumescent Lidocaine and Epinephrine
Subcutaneous injection of a relatively large volume (125ml to 250ml) of a relatively dilute solution of lidocaine (1gm/L) and epinephrine (1mg/L or 2mg/L).
Also known as: Tumescent Local Anesthesia
Adverse Events
the incidence of any clinically significant adverse event associated with TLE injection, such as pain at injection site, vasovagal event, tachycardia, infection
Time frame: up to 24 hours
Numerical Pain Scale (NPS)
Numerical Pain Scale (NPS) score following each injection, where the range of he scale is 0 to 10, and where 0= "no pain" and 10="worst imaginable pain"
Time frame: immediately after intervention
Pulse Rate
Measure difference between pulse rates before and after subcutaneous injection of 250ml of TLE.
Time frame: up to 30 minutes after intervention
Blood Pressure Changes
Measure the differences between systolic and diastolic blood pressures before and after subcutaneous injection of 250ml of TLE.
Time frame: up to 30 minutes after intervention
EKG rhythm changes
EKG rhythm strips will be recorded before and after 250ml of TLE and any significant changes will be documented. Prior to the initial subcutaneous injection of the TLE solution, the EKG rhythm will be noted and recorded. For example, if the "pre-TLE" rhythm is "Normal Sinus Rhythm (NSR)" this observation will be recorded. After the subcutaneous TLE injection, a second EKG rhythm will be recorded. The analysis of the these two EKG rhythm strips will provide a dichotomous outcome variable: "no clinically significant EKG change" or "potentially significant EKG change." If there is a significant EKG rhythm strip change, then any relevant clinical details or observations will be recorded.
Time frame: up to 30 minutes after intervention
Human-Factors Associated with subcutaneous injection of a largfe volume of a TLE solution.
Human-factor, or user interface difficulties encountered during the TLE injection process will be observed and a narrative of the observations will be recorded. The TLE-RCT is intended to demonstrate that any layperson can give a 125ml subcutaneous injection of a TLE in a manner that is safe and effective and essentially non-inferior to a similar injection administered by a physician. We will observe and record an apparent difficulties experience by the layperson when giving the injection. We will ask questions of the layperson to determine if the "instructions for use" are sufficient, and if not, we will record their suggestions for improvement.
Time frame: during the intervention
Plan to share: Yes — Other researcher, who wish to replicate our RCT-TLE trial will be provided with de-identified data upon request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Jeffrey Alan Klein, MD