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| Name | Class |
|---|---|
| Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hematoma Block | Active Comparator | Participants will receive a hematoma block only. Under aseptic conditions, 5-10 mL of 2% mepivacaine will be injected directly into the fracture hematoma using a 25-27 gauge needle. No additional nerve block will be performed. This technique is currently the standard of care in the Emergency Department for closed reduction of displaced distal radius fractures. |
|
| Hematoma Block + Median Nerve Block | Experimental | Participants will receive both a hematoma block and a median nerve block. Median nerve block will be administered at the wrist using anatomical landmarks: 3-5 mL of 2% mepivacaine injected between palmaris longus and flexor carpi radialis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematoma Block | Procedure | Injection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity During Closed Reduction | 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. | During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting). |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and Baseline Characteristics | Age, sex, fracture side (left/right), and prior use of analgesic or psychiatric medication will be collected for subgroup analyses. | At enrollment (baseline). |
| Incidence of Adverse Events Related to Anesthetic Techniques |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Quality of Reduction | 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. | Immediately after closed reduction and casting. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 12 de Octubre University Hospital | Madrid | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42295389 | Derived | Guerrero-Serrano JA, Santamaria-Lopez A, Garcia-Lamas L, Jimenez-Diaz V, Gonzalez-Fernandez A, Cecilia D. Does the addition of peripheral nerve blocks improve analgesia during distal radius fracture reduction? A prospective, randomized, multicenter clinical trial. Eur J Trauma Emerg Surg. 2026 Jun 15;52(1):191. doi: 10.1007/s00068-026-03245-x. |
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De-identified individual participant data (IPD) collected during the trial that underlie the primary and secondary outcomes will be shared. This includes pain scores (VAS values), demographic information (age, sex, fracture side, prior medication use), and adverse event data. No information that could directly identify a participant (e.g., names, dates of birth, hospital ID numbers) will be included. Requests should be directed to the Principal Investigator (jaguerrero14@hotmail.com)
IPD Sharing Start Date:
Approximately 6 months after publication of the primary study results (end-2026).
IPD Sharing End Date:
Data will be available for 5 years after publication (end-2031).
Who will be able to access the IPD and supporting information:
Qualified researchers with a methodologically sound proposal will be able to access the data. Access will be considered for investigators affiliated with academic institutions or healthcare organizations who intend to use the data for research aligned with the aims of this study.
What they will be able to access:
De-identified individual participant data underlying the primary and secondary outcomes (VAS pain scores, demographics, adverse event data), as well as the study protocol, statistical analysis plan, and data dictionary.
How they will be able to access it:
Researchers may request access by contacting the Principal Investigator. Following approval of the proposal by the study investigators, the dataset and supporting documents will be transferred using secure, encrypted methods to protect confidentiality.
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Median Nerve Block | Procedure | Injection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks. |
|
Documentation of complications such as infection at injection site, hematoma, intravascular injection, systemic anesthetic toxicity (e.g., seizures, arrhythmia), or neuritis. |
| From intervention until hospital discharge (90-120 minutes post-casting). |
| D010468 |
| Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |