Clinical Trials Directory

Trials / Completed

CompletedNCT07183904

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Hospital Universitario 12 de Octubre · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREHematoma BlockInjection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions.
PROCEDUREMedian Nerve BlockInjection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks.

Timeline

Start date
2024-01-01
Primary completion
2025-01-17
Completion
2025-03-05
First posted
2025-09-19
Last updated
2025-09-19

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07183904. Inclusion in this directory is not an endorsement.