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Completed

NCT Number: NCT07183904

Nerve and Hematoma Blocks for Pain Relief During Distal Radius Fracture Reduction

Distal radius fractures, commonly known as wrist fractures, are among the most frequent injuries seen in emergency departments. These injuries often require a closed reduction, a procedure in which the broken bone is manipulated back into place without surgery. One of the main challenges during this procedure is providing adequate pain control.

Traditionally, many hospitals use a "hematoma block," which means injecting a local anesthetic directly into the site of the fracture. This technique is simple and generally safe, but it does not always provide enough pain relief. Some patients continue to experience significant discomfort, especially in the fingers, during the traction and manipulation required to realign the bone.

Another option is to block the median nerve at the wrist. The median nerve supplies sensation to the thumb, index, and middle fingers. When combined with a hematoma block, this technique may improve digital pain relief during fracture reduction. However, this combined approach has not been well studied in Spain, and there is limited high-quality evidence worldwide.

The purpose of this study is to compare two methods of pain control during closed reduction of displaced distal radius fractures in adults: Hematoma block alone versus Hematoma block combined with median nerve block.

We hypothesize that the combined approach will reduce pain more effectively than the hematoma block alone.

The study is designed as a prospective, multicenter, randomized clinical trial involving 112 adult patients treated at two hospitals in Madrid (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe). Eligible participants are adults aged 18 to 100 years with an acute distal radius fracture (less than 48 hours old) requiring closed reduction. Patients will be randomly assigned to one of the two treatment groups.

Pain will be assessed using a Visual Analog Scale (VAS) at three key moments: during finger traction, during the reduction itself, and at hospital discharge (90-120 minutes after casting). Other information such as age, sex, fracture side, and prior use of pain or psychiatric medication will also be collected.

By answering whether the addition of a median nerve block improves pain control, this study could help establish a new protocol for managing distal radius fractures. If effective, this approach may lead to greater comfort for patients, higher satisfaction, and better overall outcomes in emergency care.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 100 years.
  • Diagnosis of acute displaced distal radius fracture (< 48 hours since injury).
  • Indication for closed reduction and immobilization.
  • Ability to provide informed consent.

Exclusion criteria

  • Age under 18 years or open physes on plain radiograph.
  • Open or pathological distal radius fractures.
  • Local infection at or near the planned injection site.
  • Significant neurological disease or cognitive impairment interfering with study participation.
  • Presence of osteosynthesis material in the same segment of the affected limb.
  • Known allergy or contraindication to local anesthetics used in the study.

Treatment and study plan

Hematoma Block

Procedure

Injection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions.

Median Nerve Block

Procedure

Injection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks.

Primary outcomes

  1. Pain Intensity During Closed Reduction

    Time frame: During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting).

    Pain will be measured using a 10-cm Visual Analog Scale (VAS, 0 = no pain, 10 = worst imaginable pain). Scores will be recorded at the wrist and fingers during traction, manipulation, and at discharge.

Secondary outcomes

  1. Demographic and Baseline Characteristics

    Time frame: At enrollment (baseline).

    Age, sex, fracture side (left/right), and prior use of analgesic or psychiatric medication will be collected for subgroup analyses.

  2. Incidence of Adverse Events Related to Anesthetic Techniques

    Time frame: From intervention until hospital discharge (90-120 minutes post-casting).

    Documentation of complications such as infection at injection site, hematoma, intravascular injection, systemic anesthetic toxicity (e.g., seizures, arrhythmia), or neuritis.

Other outcomes

  1. Radiographic Quality of Reduction

    Time frame: Immediately after closed reduction and casting.

    Post-reduction radiographs will be evaluated according to the American Academy of Orthopaedic Surgeons (AAOS) and American Society for Surgery of the Hand (ASSH) criteria for acceptable distal radius reduction.

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

  • Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre

Registry information

Official study title

Analgesic Efficacy of Combined Hematoma and Peripheral Nerve Block Versus Isolated Hematoma Block in the Reduction ff Distal Radius Fractures: A Prospective, Randomized, Multicenter Clinical Trial

Acronym: BRAVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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