Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine (TLE) by Laypersons: a Double-blind, Non-inferiority, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
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.
详细描述
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
- Pre-hospital treatment of a snakebite envenomation (SBE)
- Dermatologic surgical procedures totally by local anesthesia
- Pure sensory regional anesthesia for significant cutaneous and musculoskeletal pain.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, Care Providers, Investigator and Outcome Assessors will not know the concentration of epinephrine, either 1mg/L or 2mg/L, in the tumescent solution of lidocaine (1gm/L) to be injected subcutaneous in a participant.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Subcutaneous 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.
干预措施: Tumescent Lidocaine and Epinephrine (Drug)
Subcutaneous 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.
干预措施: Tumescent Lidocaine and Epinephrine (Drug)
Subcutaneous injection of 250ml by a physician into a volunteer (Arm III)
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.
干预措施: Tumescent Lidocaine and Epinephrine (Drug)
结局指标
主要结局
Adverse Events
时间窗: up to 24 hours
the incidence of any clinically significant adverse event associated with TLE injection, such as pain at injection site, vasovagal event, tachycardia, infection
次要结局
- Numerical Pain Scale (NPS)(immediately after intervention)
- Blood Pressure Changes(up to 30 minutes after intervention)
- Pulse Rate(up to 30 minutes after intervention)
- EKG rhythm changes(up to 30 minutes after intervention)
- Human-Factors Associated with subcutaneous injection of a largfe volume of a TLE solution.(during the intervention)
研究者
Jeffrey Alan Klein, MD
Principal Investigator
HK Surgical, Inc.