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

NCT04733781 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: TLE-RCT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.

Conditions

Venomous Snakebites; Local Anesthesia; Painless Injection; Regional Anesthesia; Dermatologic Surgery; Cutaneous Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  the incidence of any clinically significant adverse event associated with TLE injection, such as pain at injection site, vasovagal event, tachycardia, infection

  up to 24 hours

Secondary Outcomes (5)

• Numerical Pain Scale (NPS)

  immediately after intervention

• Pulse Rate

  up to 30 minutes after intervention

• Blood Pressure Changes

  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

Study Arms (3)

Subcutaneous injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I):

ACTIVE COMPARATOR

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

Subcutaneous injection of 125ml by a physician and 125ml by another volunteer (Arm II):

ACTIVE COMPARATOR

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

Subcutaneous injection of 250ml by a physician into a volunteer (Arm III)

ACTIVE COMPARATOR

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

Interventions

Tumescent Lidocaine and Epinephrine DRUG

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

Subcutaneous injection of 125ml by a physician and 125ml by another volunteer (Arm II):; Subcutaneous injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I):; Subcutaneous injection of 250ml by a physician into a volunteer (Arm III)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jeffrey Alan Klein, MD: lead

Study Sites (1)

HK Dermatology Care Center

San Juan Capistrano, California, 92675, United States

Location

Related Publications (7)

• Makdisi JR, Kim DP, Klein PA, Klein JA. Tumescent contravenom: murine model for prehospital treatment of Naja naja neurotoxic snake envenomation. Int J Dermatol. 2018 May;57(5):605-610. doi: 10.1111/ijd.13877. Epub 2018 Feb 20.

  PMID: 29460967 BACKGROUND

• Klein JA, Jeske DR. Estimated Maximal Safe Dosages of Tumescent Lidocaine. Anesth Analg. 2016 May;122(5):1350-9. doi: 10.1213/ANE.0000000000001119.

  PMID: 26895001 BACKGROUND

• Klein JA, Langman LJ. Prevention of Surgical Site Infections and Biofilms: Pharmacokinetics of Subcutaneous Cefazolin and Metronidazole in a Tumescent Lidocaine Solution. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1351. doi: 10.1097/GOX.0000000000001351. eCollection 2017 May.

  PMID: 28607871 BACKGROUND

• Klein JA. Tumescent technique for local anesthesia improves safety in large-volume liposuction. Plast Reconstr Surg. 1993 Nov;92(6):1085-98; discussion 1099-100.

  PMID: 8234507 BACKGROUND

• Klein JA. The tumescent technique for liposuction surgery. J Am Acad Cosmetic Surg, 1987; 4:263-267.

  BACKGROUND

• US Patent 10,786,483 B2. JA Klein, PA Klein, BA Klein. Tumescent Contravenom Drug Delivery (Sep 29, 2020).

  BACKGROUND

• US Patent 10,493,024 B2. Klein. Tumescent infiltration drug delivery of high subcutaneous drug concentrations with prolonged local and systemic effects and minimal local or systemic toxicity (Dec 3, 2019).

  BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Jeffrey A Klein, MD

CONTACT

(949) 283-1070; jeff@kleinmd.com

Michele Horwich, RN

CONTACT

(949) 248-1632; michele@kleinmd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double-blind, non-inferiority, randomized clinical trial

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 2, 2021
• Study Start: February 22, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 7, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available at the time that the data is first presented in a public forum.
• Access Criteria: All information will be uploaded to www.tumescent.com

Locations

US (1)