Trial · NCT04733781
Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons
NCT04733781, Phase 2, Phase 3, Unknown, Jeffrey Alan Klein, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons. Trials, record NCT04733781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04733781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons
- NCT number
- NCT04733781
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Jeffrey Alan Klein, MD
- Conditions
- Venomous Snakebites, Local Anesthesia, Painless Injection, Regional Anesthesia, Dermatologic Surgery, Cutaneous Pain, Musculoskeletal Pain
- Interventions
- Tumescent Lidocaine and Epinephrine
- First posted
- 2021-02-02
- Last updated
- 2021-02-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | 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 |
| Secondary | Numerical Pain Scale (NPS) | immediately after intervention | 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" |
| Secondary | Pulse Rate | up to 30 minutes after intervention | Measure difference between pulse rates before and after subcutaneous injection of 250ml of TLE. |
| Secondary | Blood Pressure Changes | up to 30 minutes after intervention | Measure the differences between systolic and diastolic blood pressures before and after subcutaneous injection of 250ml of TLE. |
| Secondary | EKG rhythm changes | up to 30 minutes after intervention | 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. |
| Secondary | Human-Factors Associated with subcutaneous injection of a largfe volume of a TLE solution. | during the intervention | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04733781
GET https://conductscience.org/api/trials/v1/NCT04733781/registered