Evaluation of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block Using Lidocaine Hydrochloride or Ropivacaine Hydrochloride in Distal Radius Fracture Reduction

The primary objective of this study is to evaluate the **feasibility** of the lateral infraclavicular plexus brachialis (LIC) block for the acute closed reduction of distal radius fractures. This will be achieved by comparing the pain-relieving and muscle-relaxing properties of the LIC block using short- and long-acting local anesthetics, specifically **lidocaine** and **ropivacaine**, in different concentrations but at the same volume. The clinical relevance of this objective lies in determining the effectiveness of the LIC block in providing adequate anesthesia and muscle relaxation during the repositioning and plastering procedures, which are critical for successful fracture management. The study will also assess additional patient-related and block-related factors to further understand the feasibility of this anesthetic approach.

The clinical trial involves participants with **distal radius fractures** requiring acute closed reduction. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. The total number of participants is not provided, as the sponsor did not give this information. Participants were selected based on the principal inclusion criterion of having a distal radius fracture necessitating closed reduction. The trial does not specifically target a vulnerable population, and no particular lifestyle considerations such as diet or physical activity are highlighted. The study aims to evaluate the feasibility of the lateral infraclavicular plexus brachialis block in managing these fractures, focusing on pain relief and muscle relaxation during the procedure.

The clinical trial is designed to evaluate the **feasibility** of the lateral infraclavicular plexus brachialis block for the acute closed reduction of distal radius fractures. This is a randomized, controlled, non-inferiority trial comparing the pain-relieving and muscle-relaxing properties of short-acting and long-acting local anesthetics, specifically **lidocaine hydrochloride** and **ropivacaine hydrochloride**, both administered as a solution for injection via perineural use. The trial will assess the efficacy of these anesthetics in terms of motor and sensory blockade during the repositioning of fractures, as well as other patient-related and block-related factors.

The trial will commence with a screening visit to confirm eligibility, which includes patients with distal radius fractures requiring closed reduction. Participants will be randomly assigned to receive either lidocaine or ropivacaine. The trial is double-blind, ensuring that neither the participants nor the investigators know which treatment is being administered, thus minimizing bias. The primary endpoint is the incidence of successful blockade 45 minutes after block performance. The trial is expected to start recruitment on March 1, 2024, and conclude by August 1, 2024, with the overall duration of participant involvement being approximately one day, as the maximum treatment period is one day.

Study visits will include the initial screening visit, the treatment visit where the block is performed, and an end-of-study visit to assess the primary endpoint. Follow-up visits are not specified, given the short duration of the trial. Participants may be terminated early from the study if they experience adverse reactions to the anesthetics or if they withdraw consent. The trial is categorized as low-intervention, involving only adult patients and using approved drugs in accordance with their summary of product characteristics.

The clinical trial involves the administration of **Ropivacaine Hydrochloride** under the brand name Ropivacain Fresenius Kabi. This experimental medication is provided in the form of a **solution for injection**. The maximum daily dose is 60 mg, with a total dose not exceeding 60 mg, administered perineurally. The treatment period is limited to one day. The pharmaceutical product is manufactured by Fresenius Kabi AB and is chemically derived. The administration of this medication is monitored to ensure compliance with the dosing schedule.

Another experimental treatment in the trial is a different formulation of **Ropivacaine Hydrochloride**, also under the brand name Ropivacain Fresenius Kabi. This formulation is similarly provided as a solution for injection, with a maximum daily and total dose of 150 mg. The administration route is perineural, and the treatment period is also restricted to one day. This formulation is also produced by Fresenius Kabi AB and is chemically sourced. Participant compliance with the dosing regimen is closely monitored.

The comparator treatment used in the study is Lidokain-adrenalin SAD, which contains the active substances **Epinephrine** and **Lidocaine Hydrochloride**. This medication is also provided as a solution for injection, with a maximum daily and total dose of 300 mg. The administration is perineural, and the treatment period is limited to one day. The product is manufactured by AMGROS I/S and is chemically derived. Compliance with the administration schedule is ensured throughout the trial.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the incidence of successful blockade 45 minutes after the performance of the block. This endpoint will be measured to determine the effectiveness of the lateral infraclavicular plexus brachialis (LIC) block in providing pain relief and muscle relaxation during the acute closed reduction of distal radius fractures. The trial will compare the efficacy of short- and long-acting local anesthetics, specifically **lidocaine** and **ropivacaine**, administered in different concentrations but at the same volume. The assessment will focus on both motor and sensory blockade during the repositioning procedure. The trial is designed as a randomized controlled non-inferiority study, ensuring that the efficacy of the LIC block with the two anesthetics is rigorously evaluated under controlled conditions.