drugset / Trial / NCT04733781
Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons
RandomizedSingle-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-02-22
- Primary completion
- 2021-06-01
- Completion
- 2021-06-07
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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).
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Epinephrine | Other / unclassified | 0.001 mg/ml | Subcutaneous |
| Comparator | Epinephrine | Other / unclassified | 0.002 mg/ml | Subcutaneous |
| Comparator | Lidocaine | Other / unclassified | 1 mg/ml | Subcutaneous |