Evaluation of Lidocaine Hydrochloride and Ropivacaine Hydrochloride Combination on Infraclavicular Brachial Plexus Block Efficacy in Hand Surgery Patients

The primary objective of this study is to evaluate the **lateral infraclavicular plexus brachialis (LIC) block** as the sole anesthesia method for hand surgery. The study aims to compare the duration and onset time of the LIC block when using a combination of short- and long-acting local anesthetics, specifically **lidocaine** and **ropivacaine**, at varying concentrations but consistent volume. Additionally, the study will assess both motor and sensory blockade properties. This investigation is clinically relevant as it seeks to optimize anesthesia techniques for patients undergoing hand surgery, potentially improving patient outcomes and procedural efficiency.

The clinical trial involves **patients undergoing hand surgery** for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint. The study population includes both male and female participants, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their need for specific hand surgeries, and no additional lifestyle considerations such as diet or physical activity were specified. The trial aims to evaluate the efficacy of the lateral infraclavicular plexus brachialis block as the sole anesthesia method for these surgical procedures.

The clinical trial is designed to evaluate the **lateral infraclavicular plexus brachialis (LIC) block** as the sole anesthesia for hand surgery, specifically in patients undergoing procedures for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint. This study is a randomized, controlled trial that will compare the duration and onset time of the LIC block using a combination of short- and long-acting local anesthetics, namely **ropivacaine hydrochloride** and a combination of **epinephrine** and **lidocaine hydrochloride**. The trial will assess both motor and sensory blockade properties.

The trial is expected to commence recruitment on March 1, 2024, and conclude by June 15, 2024. Participants will be involved in the study for a maximum treatment period of one day, as the trial involves a single administration of the anesthetic solution. The study will include several key visits: an initial screening visit to confirm eligibility based on inclusion criteria, which requires patients to be undergoing specific hand surgeries. Follow-up visits will be conducted to monitor the onset and duration of sensory and motor blockades, as well as to record the time to breakthrough pain. The end-of-study visit will occur once the effects of the anesthetic have completely worn off, and all necessary data have been collected.

Participants may be withdrawn from the study if they experience adverse reactions to the anesthetics, if they withdraw consent, or if they do not adhere to the study protocol. The primary endpoint of the trial is the total time to breakthrough pain, measured from the completion of the LIC block to the first sensation of pain in the surgical area. Secondary endpoints include the onset of sensory block, total duration of sensory and motor blockades, and the degree of motor blockade at sensory onset. The trial is categorized as low-intervention, involving only adult patients and utilizing approved drugs in accordance with their summary of product characteristics.

The clinical trial involves the administration of **Ropivacaine Hydrochloride** as an experimental medication. This compound is provided under the brand name Ropivacain Fresenius Kabi, manufactured by Fresenius Kabi AB. It is formulated as a **solution for injection** and is intended for **perineural use**. The maximum daily dose is 800 mg, with a total dose not exceeding 4 mg/kg. The treatment period is limited to one day. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen.

Another experimental treatment in the study is a combination of **Epinephrine** and **Lidocaine Hydrochloride**, marketed as Lidokain-adrenalin SAD by AMGROS I/S. This product is also a **solution for injection** and is used for **perineural administration**. The maximum daily dose for this combination is 1000 mg, with a total dose limit of 7 mg/kg. The treatment duration is similarly restricted to one day. Compliance with the dosing schedule is closely monitored to maintain the integrity of the trial data.

In this trial, there is no use of a placebo or other non-experimental treatments. The focus is on comparing the effects of the experimental medications on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block. The study aims to evaluate both motor and sensory blockade properties of the treatments under investigation.

Efficacy in this clinical trial will be assessed by evaluating both primary and secondary endpoints related to the **lateral infraclavicular plexus brachialis (LIC) block** used as anesthesia for hand surgery. The primary endpoint is the total time to breakthrough pain, measured from the completion of the LIC block to the first sensation of pain from the surgical area. This will provide a direct measure of the duration of analgesic efficacy.

Secondary endpoints include the onset of sensory block, total duration of sensory blockade, total duration of motor blockade, and the degree of motor blockade at sensory onset. These parameters will be measured from the completion of the LIC block to specific timepoints, such as the complete sensory blockade and 45 minutes after block performance. The assessment of these endpoints will involve monitoring the sensory and motor blockade properties, providing a comprehensive evaluation of the anesthetic effects of the combination of lidocaine and ropivacaine.