Acute Distal Radius Fracture, Displaced Distal Radius Fracture
Conditions
Keywords
Distal Radius Fracture, Hematoma Block, Median Nerve Block, Pain Management, Closed Reduction
Brief summary
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.
Interventions
Injection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions.
Injection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks.
Sponsors
Study design
Intervention model description
* Two-arm design with participants randomized 1:1. * One group receives hematoma block alone (control). * The other group receives hematoma block combined with median nerve block (intervention). * Randomization is stratified by study center (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe) and balanced for sex, age, fracture side, and prior medication use. * Each participant is assigned to only one study arm and followed prospectively.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Closed Reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Demographic and Baseline Characteristics | At enrollment (baseline). | Age, sex, fracture side (left/right), and prior use of analgesic or psychiatric medication will be collected for subgroup analyses. |
| Incidence of Adverse Events Related to Anesthetic Techniques | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Quality of Reduction | 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. |
Countries
Spain