Evaluation of Ultrasound-Guided Brachial Plexus Nerve Block with Epinephrine and Lidocaine Hydrochloride for Closed Reduction of Distal Radius Fracture in Adults

The primary objective of the study is to evaluate the beneficial and harmful effects of an **ultrasound-guided brachial plexus nerve block** for patients with a **distal radius fracture** managed with closed reduction, compared to standard care. This is clinically relevant as it aims to determine the efficacy and safety of this nerve block technique, potentially offering an alternative to traditional methods for pain management and procedural success in the acute setting of distal radius fractures.

The clinical trial involves **adults** aged 18 years and older who have sustained a **distal radius fracture** requiring acute closed reduction. The study population includes both male and female participants, and it does not involve any vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants were selected based on the need for closed reduction of the fracture, and no specific lifestyle considerations such as diet or physical activity were highlighted. The trial aims to assess the effects of an ultrasound-guided brachial plexus nerve block compared to standard care in managing this condition.

The clinical trial is designed to evaluate the **beneficial and harmful effects** of an ultrasound-guided brachial plexus nerve block for patients with a **distal radius fracture** managed with closed reduction, compared to standard care. This is a randomized, double-blind, controlled trial involving adult participants aged 18 years and older who require closed reduction for a distal radius fracture. The trial is categorized as low-intervention, utilizing approved drugs in accordance with their summary of product characteristics. The trial is expected to commence recruitment on October 1, 2024, and conclude by March 1, 2027.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the principal inclusion criteria. The primary endpoint is the cumulative proportion of patients requiring distal radius fracture surgery within 90 days post-closed reduction. Secondary endpoints include a composite outcome of treatment-related complications, the Patient Rated Wrist Evaluation (PRWE) at 90 days, maximum pain score during closed reduction, and the proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

The expected length of participant involvement is up to 90 days post-closed reduction, with follow-up visits scheduled to monitor outcomes and assess any complications. Conditions that may lead to early termination from the study include the occurrence of severe adverse events or withdrawal of consent by the participant. The trial will utilize **lidocaine hydrochloride** and **epinephrine** in a solution for injection, administered perineurally, with a maximum daily dose of 7 mg/kg and a maximum treatment period of one day. The trial aims to provide valuable insights into the efficacy and safety of the intervention, contributing to improved management strategies for distal radius fractures.

The clinical trial involves the administration of **Lidocaine-adrenaline SAD**, a **solution for injection**. This experimental medication contains the active substances **epinephrine** and **lidocaine hydrochloride**. The pharmaceutical form is a solution intended for **perineural use**. The dosage is calculated based on the participant's body weight, with a maximum daily dose of 7 mg/kg and a maximum total dose of 7 mg/kg. The treatment period is limited to a single day. The administration of the solution is guided by ultrasound to perform a brachial plexus nerve block, which is a technique used to manage pain in patients with a distal radius fracture undergoing closed reduction.

In this study, the experimental treatment is compared to standard care, which serves as the non-experimental treatment. The standard care involves a haematoma block, a common procedure for pain management in similar clinical scenarios. The trial aims to evaluate the beneficial and harmful effects of the ultrasound-guided brachial plexus nerve block compared to the standard care approach. Participant compliance with the dosing schedule and administration protocol is monitored throughout the trial to ensure adherence to the study design.

Efficacy in the clinical trial titled "Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults – The BLOCK Trial" will be assessed using both primary and secondary endpoints. The primary endpoint is the cumulative proportion of patients requiring surgery for a distal radius fracture within 90 days following closed reduction. This endpoint will provide a direct measure of the intervention's effectiveness in reducing the need for surgical intervention.

Secondary endpoints include a composite outcome of treatment-related complications, such as loco-regional neurological complications, local anesthetic systemic toxicity, soft tissue injuries, infection at the needle puncture site, vessel puncture requiring treatment, pneumothorax, allergic reactions, new bone or joint injury, and pulmonary embolism within 90 days post-reduction. Additionally, the Patient Rated Wrist Evaluation (PRWE) will be conducted 90 days after closed reduction to assess patient-reported outcomes. The maximum pain score during closed reduction will be measured using the Numerical Rating Scale (NRS) from 0 to 10. The proportion of patients with unacceptable radiographic fracture position immediately after closed reduction will also be evaluated according to the American Academy of Orthopaedic Surgeons (AAOS) guidelines.