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

NCT ID: NCT07183904

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hematoma Block

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.

Group Type: ACTIVE_COMPARATOR

Hematoma Block

Intervention Type: PROCEDURE

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

Hematoma Block + Median Nerve Block

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.

Group Type: EXPERIMENTAL

Hematoma Block

Intervention Type: PROCEDURE

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

Median Nerve Block

Intervention Type: PROCEDURE

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

Interventions

Hematoma Block

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

Intervention Type: PROCEDURE

Median Nerve Block

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: lead

Responsible Party

Jose Antonio Guerrero Serrano

Dr. (Orthopaedic Surgeon)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

12 de Octubre University Hospital

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

24/272

Identifier Type: -

Identifier Source: org_study_id