Comparison of Lidocaine and Ropivacaine in Ultrasound-Guided Nerve Block for Patients with Wrist Fractures Requiring Closed Reduction

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What is this study about?

This study focuses on treating patients with distal radius fractures (broken wrist bones) that require closed reduction (a procedure to realign the broken bones without surgery). The study compares two different local anesthetic medications: Ropivacaine and Lidocaine with epinephrine, which are drugs used to block pain and relax muscles in the affected area.

The purpose of this research is to evaluate how well these medications work when given through a nerve block called lateral infraclavicular brachial plexus block. This is an injection technique where medication is delivered near the nerves in the shoulder area using ultrasound guidance to help control pain during the bone realignment procedure.

During the study, participants will receive one of these pain-blocking medications through an injection. The medications will be given in different strengths but in the same amount of liquid. The effectiveness of the nerve block will be checked 45 minutes after the injection is given, before proceeding with the bone realignment and casting procedure.

1 Initial block procedure

You will receive an ultrasound-guided lateral infraclavicular block (a nerve block injection near your collarbone) to manage pain during the wrist fracture reduction procedure.

The medical team will administer either Lidocaine or Ropivacaine as an injection solution. The specific medication will be selected randomly.

The medication will be delivered through perineural use (injection around the nerves that control your arm).

2 Waiting period

After receiving the nerve block, there will be a 45-minute observation period.

During this time, the medical team will monitor how well the nerve block is working by checking your arm’s sensation and movement.

3 Fracture reduction procedure

Once the nerve block takes effect, the medical team will perform the closed reduction of your wrist fracture.

This procedure involves realigning the broken bones without making any surgical incisions.

After the bones are properly aligned, a plaster cast will be applied to maintain the correct position.

4 Assessment and monitoring

The medical team will evaluate the success of both the nerve block and the fracture reduction procedure.

They will assess your pain levels and the effectiveness of the pain relief provided by the nerve block.

The total duration of your participation will be limited to the time needed for the procedure and immediate follow-up assessment.

Who Can Join the Study?

  • Must have a distal radius fracture (broken bone in the lower part of the forearm near the wrist) that requires closed reduction (a procedure to realign the broken bone without surgery)
  • Must be an adult (18 years or older)
  • Can be either male or female
  • Must be able to provide informed consent to participate in the study
  • Must not belong to any vulnerable population groups (such as prisoners, mentally disabled individuals, or others unable to give informed consent)
  • Must be willing to receive a lateral infraclavicular plexus brachialis block (a type of nerve block injection near the collarbone to provide pain relief and muscle relaxation)

Who Cannot Join the Study?

  • Age below 18 or above 65 years
  • Known allergies to local anesthetics (medications used for numbing)
  • Patients with multiple fractures (more than one broken bone)
  • Infection at the site where the nerve block would be performed
  • Neurological disorders affecting the injured arm (conditions affecting nerves)
  • Inability to give informed consent
  • Pregnancy or breastfeeding
  • Previous surgery in the affected arm
  • Blood clotting disorders or use of blood-thinning medications
  • Open fractures (where the bone has broken through the skin)
  • Chronic pain conditions affecting the injured arm
  • Known heart or lung disease that could affect anesthesia safety
  • Language barriers that prevent understanding of study procedures
  • Participation in another clinical trial within the past 30 days

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hgiknyje Hsyrpjij Hillerød Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.03.2024

Trial locations

Lidocaine
A local anesthetic medication used for pain relief during medical procedures. It works quickly to numb the area and block pain signals. In this trial, it is used in a nerve block procedure to help reduce pain during the treatment of wrist fractures.

Ropivacaine
A local anesthetic medication that provides longer-lasting pain relief compared to other similar medications. It works by blocking nerve signals to prevent pain sensation. In this trial, it is used as part of a nerve block procedure to manage pain during the repositioning of broken wrists.

Ultrasound guided lateral infraclavicular brachial plexus block
This is not a medication but a medical procedure where local anesthetic is injected near the nerves in the shoulder area using ultrasound guidance. This technique helps ensure accurate placement of the anesthetic to block pain signals in the arm during the treatment of wrist fractures.

Distal Radius Fracture – A break in the radius bone near the wrist joint, which is one of the most common types of bone fractures. The fracture typically occurs within two inches of the wrist joint, where the bone becomes wider and more cancellous. It can result from a fall onto an outstretched hand or direct trauma to the wrist area. The break may cause visible deformity of the wrist, swelling, and limited mobility of the affected area. In cases requiring closed reduction, the broken bone pieces need to be realigned without making surgical incisions.

Trial ID:
2024-510572-20-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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