Evaluation of Continuous Intravenous Lidocaine Hydrochloride Monohydrate on Postoperative Discomfort in Critical Care Patients

The primary objective of this study is to evaluate whether the continuous intravenous administration of **lidocaine** during the first 48 hours post-operatively enhances patients' perceived comfort during their stay in the intensive care unit and continuous monitoring unit. This is clinically relevant as improving comfort can potentially lead to better recovery outcomes and patient satisfaction in postoperative critical care settings.

Secondary objectives include determining whether the administration of lidocaine reduces:

• Certain types of discomfort, including noise, thirst, pain, presence of medical devices, sleep disturbances, dyspnoea, anxiety, and depression.
• Post-operative opioid consumption.
• The duration of invasive mechanical ventilation.
• The incidence of failed weaning from invasive mechanical ventilation during the critical care stay.
• The duration of sedation.
• The length of stay in critical care and the total length of hospital stay.
• Mortality on the 30th postoperative day.
• The incidence of healthcare-associated pneumonia.
• The incidence of delirium in critical care.
• Any adverse effects associated with lidocaine administration.

The clinical trial focuses on **postoperative critical care** and involves a study population comprising both male and female subjects. The age range of participants includes adults and older adults, specifically those aged 18 years and above. The trial population was selected based on their immediate postoperative admission to critical care, with an anticipated stay of at least 48 hours. Participants are required to be major patients, and the trial includes individuals undergoing various types of surgeries such as exploratory laparotomy, cardiac surgery, heavy orthopedic surgery, and vascular surgery at risk of complications. The study population is characterized by a vulnerable status, necessitating informed consent obtained from the patient or a legal representative. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the effect of continuous intravenous administration of **lidocaine hydrochloride monohydrate** on discomfort in postoperative critical care inpatients. This study is a randomized, double-blind, controlled trial, with a placebo group receiving **sodium chloride**. The trial aims to determine whether lidocaine improves patients' perceived comfort during their stay in the intensive care unit over the first 48 hours post-operatively. The trial is expected to commence recruitment on April 1, 2025, and conclude by May 1, 2027.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as being a major patient, immediate postoperative admission to critical care, and an anticipated stay of at least 48 hours. Informed consent must be obtained. Follow-up visits will monitor the primary endpoint, which is the overall score on the IPREA questionnaire, assessed within 24 hours of discharge from critical care or within 24 hours of the 30th day of hospitalization. Secondary endpoints include individual IPREA item scores, cumulative opiate consumption, duration of mechanical ventilation, and incidence of care-associated pneumonia, among others.

The expected length of participant involvement is up to 30 days post-operatively, with conditions for early termination including withdrawal of consent or adverse reactions attributable to lidocaine. The trial will ensure rigorous monitoring to maintain participant safety and data integrity throughout the study duration.

The clinical trial involves the administration of **Lidocaine Hydrochloride Monohydrate**, which is utilized as the experimental medication. This compound is provided in the form of a **solution for injection**. The administration route is **intravenous**, with a maximum daily dosage of 1.28 milliliters per kilogram and a total maximum dosage of 4.48 milliliters per kilogram over the treatment period. The treatment is administered continuously over a period of 48 hours post-operatively, aiming to improve patient comfort in critical care settings. The active substance, Lidocaine Hydrochloride Monohydrate, is of chemical origin and is not formulated for pediatric use.

In addition to the experimental treatment, **Sodium Chloride** is employed as a comparator treatment, serving as a placebo in this study. Sodium Chloride is also provided as a **solution for injection** and administered intravenously. The maximum daily dosage is 1.28 milliliters per kilogram, with a total maximum dosage of 2.48 milliliters per kilogram over the same treatment period of 48 hours. This comparator is used to evaluate the efficacy of the experimental treatment by providing a baseline for patient comfort levels in the absence of the active experimental compound. Sodium Chloride, like Lidocaine Hydrochloride Monohydrate, is of chemical origin and is not intended for pediatric use.

Efficacy in this clinical trial will be assessed using both primary and secondary endpoints. The primary endpoint is the overall score on the IPREA questionnaire, which evaluates **discomfort** in critical care patients. This assessment will be conducted within 24 hours of discharge from critical care or, if not feasible, within 24 hours of the 30th day of hospitalization in critical care.

Secondary endpoints include a detailed analysis of specific items from the IPREA score, such as noise, thirst, pain, medical devices, sleepiness, dyspnea, anxiety, and depression. These will be measured within 24 hours before discharge from critical care or, alternatively, within 24 hours before the 30th day of hospitalization. Additional secondary endpoints involve cumulative opiate consumption over the first six post-operative days, duration of invasive mechanical ventilation, re-intubation within 48 hours of extubation, duration of sedation, length of stay in critical care, total length of hospital stay, vital status on the 30th postoperative day, incidence of care-associated pneumonia, incidence of delirium, and incidence of adverse reactions attributable to lidocaine.

The IPREA questionnaire, a validated tool, will be utilized for assessing patient discomfort. The trial will monitor these parameters at specified timepoints to ensure comprehensive data collection and analysis. The study aims to determine the impact of continuous intravenous administration of lidocaine on patient comfort during the first 48 hours post-operatively in a critical care setting.