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Study on Brachial Plexus Nerve Block with Epinephrine and Lidocaine for Adults with Distal Radius Fracture Needing Closed Reduction

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of distal radius fractures, which are breaks near the wrist end of the forearm bone. The trial will compare two methods for managing these fractures: a brachial plexus nerve block and standard care. A brachial plexus nerve block is a procedure where a numbing medication is injected near the nerves of the shoulder to block pain in the arm. The medication used in this procedure is a combination of epinephrine and lidocaine hydrochloride, which is administered as a solution for injection.

The purpose of the study is to evaluate the effects of using an ultrasound-guided brachial plexus nerve block for patients who need a closed reduction, which is a non-surgical method to realign the broken bone. Participants in the study will receive either the nerve block or standard care, and their progress will be monitored over a period of time. The study will look at various outcomes, such as the need for surgery within 90 days, any complications related to the treatment, and the level of pain experienced during the procedure.

Throughout the study, researchers will also assess the position of the fracture after the procedure and any new injuries or complications that may arise. The trial aims to provide valuable information on the benefits and risks of using a brachial plexus nerve block compared to standard care for treating distal radius fractures.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be adults aged 18 or older with a distal radius fracture requiring closed reduction.

  2. Step 2

    Treatment allocation

    Participants are assigned to receive either a brachial plexus nerve block or standard care for the closed reduction of the fracture. The nerve block is performed using ultrasound guidance.

  3. Step 3

    Administration of medication

    For those receiving the nerve block, a solution containing epinephrine and lidocaine hydrochloride is injected perineurally. This means the medication is administered near the nerves to block pain during the procedure.

  4. Step 4

    Closed reduction procedure

    The closed reduction procedure is performed to realign the fractured bone. Pain levels are monitored using a numerical rating scale from 0 to 10.

  5. Step 5

    Post-procedure monitoring

    Participants are observed for any immediate complications such as neurological issues, local anesthetic toxicity, or other procedure-related injuries.

  6. Step 6

    Follow-up assessments

    Follow-up assessments occur over a 90-day period. These include evaluating wrist function, pain levels, and any additional treatments required for the fracture.

  7. Step 7

    Final evaluation

    The primary outcome is assessed by determining the proportion of participants who require surgery within 90 days after the closed reduction. Secondary outcomes include complications, wrist function, and pain scores.

Who can join the trial?

5 criteria

  • Must be an adult, which means you need to be 18 years old or older.
  • Have a distal radius fracture, which is a break near the wrist in one of the bones of the forearm.
  • The fracture must require a closed reduction, which is a procedure to set the bone without surgery.
  • Both men and women can participate.
  • Participants should not be part of a vulnerable population, meaning they should not be in a group that needs special protection in research, like children or people with certain disabilities.

Who cannot join the trial?

4 criteria

  • Patients who have a **distal radius fracture** that does not need immediate treatment to realign the bone.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a group that is not included in the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Brachial Plexus Nerve Block

    This is a type of regional anesthesia used to numb the arm and hand. In this trial, it is performed using ultrasound guidance to ensure accuracy. The nerve block is intended to provide pain relief for patients undergoing a procedure to set a broken wrist bone, known as a distal radius fracture. By blocking the nerves in the brachial plexus, the procedure aims to reduce pain during and after the fracture reduction.

  • Standard Care

    This refers to the usual treatment provided for managing a distal radius fracture. It typically includes pain management with medications such as painkillers, and the manual setting of the bone, followed by immobilization with a cast or splint. The trial compares this standard approach to the use of a brachial plexus nerve block to assess differences in pain relief and overall outcomes.

What is already known about the treatment

Brachial Plexus Nerve Block – This is a form of regional anesthesia administered through an injection near the brachial plexus nerves, typically guided by ultrasound. It is currently being evaluated in clinical trials for its effectiveness in managing pain during the closed reduction of distal radius fractures. The main therapeutic indication is to provide pain relief during the procedure, potentially offering an alternative to standard care methods. The mechanism of action involves blocking nerve signals in the arm, preventing pain sensations from reaching the brain. It is classified as a regional anesthetic technique.

Investigated diseases

Distal Radius Fracture – A distal radius fracture is a break near the wrist end of the radius, one of the two large bones in the forearm. It often occurs when a person falls onto an outstretched hand. The fracture can cause pain, swelling, and difficulty moving the wrist or hand. In some cases, the bone fragments may shift out of alignment, requiring a procedure called closed reduction to realign them. This type of fracture is common in both young people, due to high-energy impacts, and older adults, often due to weaker bones. Recovery involves immobilization and may require physical therapy to restore full function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512191-35-00Estimated enrolment1 716 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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