Background: Local anesthetics (LAs) are regularly used to alleviate pain during medical or surgical procedures. Their use is generally considered safe, but exceeding the maximum recommended doses can lead to LA systemic toxicity, a rare but potentially lethal complication. Determining maximum safe doses is therefore mandatory before performing local anesthesia, but rules are often unclear and the factors affecting dose calculation are numerous. Mobile health apps have been shown to help clinical decision-making, but most currently available apps present significant limitations. The Local Anesthetics Dose Calculator (LoAD Calc) app was designed to overcome these limitations by taking all relevant parameters into account. Before deploying this app in a clinical setting, it should be tested to determine its effectiveness and whether clinicians would be willing to use it.
Objective: The primary objective will be to evaluate the effectiveness of the LoAD Calc app through written simulated cases. The secondary objective will be to determine whether physicians find this app easier, faster, and safer than the methods they generally use.
Methods: We describe a parallel-group randomized controlled trial protocol. Anesthesiologists working at the Geneva University Hospitals will be invited to participate. Participants will be asked to compute the maximum dose of LA in 10 simulated clinical cases using 3 different LAs. The maximum safe dose will be determined manually using the same calculation rules that were used to develop LoAD Calc, without using the app itself. An overdose will be considered any dose higher than the correct dose, rounded to the superior integer, while an underdose will be defined as the optimal calculated dose minus 20%, rounded to the inferior integer. Randomization will be stratified according to current position (resident vs registrar). The participants allocated to the LoAD Calc (experimental) group will use the LoAD Calc app to compute the maximum safe LA doses. Those allocated to the control group will be asked to use the method they generally use. The primary outcome will be the overall overdose rate. Secondary outcomes will include the overdose rate according to ideal and actual body weight and to each specific LA, the overall underdose rate, and the time taken to complete these calculations. The app's usability will also be assessed.
Results: A sample size of 46 participants will be needed to detect a difference of 10% with a power of 90%. Thus, a target of 50 participants was set to allow for attrition and exclusion criteria. We expect recruitment to begin during the winter of 2023, data analysis in the spring of 2024, and results by the end of 2024.
Conclusions: This study should determine whether LoAD Calc, a mobile health app designed to compute maximum safe LA doses, is safer and more efficient than traditional LA calculation methods.
International registered report identifier (irrid): PRR1-10.2196/53679.
Keywords: dose calculation; drug safety; information systems research; local anesthetic systemic toxicity; local anesthetics; mobile health app; study protocol; toxicity.
©Pietro Elias Fubini, Georges Louis Savoldelli, Tal Sara Beckmann, Caroline Flora Samer, Mélanie Suppan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.01.2024.