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

NCT07183904 | Completed DMC

• 1 other identifier: 24/272
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Distal Radius Fracture; Displaced Distal Radius Fracture

Keywords

Distal Radius Fracture; Hematoma Block; Median Nerve Block; Pain Management; Closed Reduction

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• Demographic and Baseline Characteristics

  At enrollment (baseline).

• Incidence of Adverse Events Related to Anesthetic Techniques

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

Other Outcomes (1)

• Radiographic Quality of Reduction

  Immediately after closed reduction and casting.

Study Arms (2)

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.

Procedure: Hematoma Block

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.

Procedure: Hematoma Block; Procedure: Median Nerve Block

Interventions

Hematoma Block PROCEDURE

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

Hematoma Block; Hematoma Block + Median Nerve Block

Median Nerve Block PROCEDURE

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

Hematoma Block + Median Nerve Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

12 de Octubre University Hospital

Madrid, Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Wrist Fractures; Agnosia

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. (Orthopaedic Surgeon)

Model Details: * 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.

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: January 1, 2024
• Primary Completion: January 17, 2025
• Study Completion: March 5, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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).
• Access Criteria: 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.

Locations

ES (1)