Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-04-14 @ 11:01 PM
Study NCT ID:
NCT07183904
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerve and Hematoma Blocks for Pain Relief During Distal Radius Fracture Reduction
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVE
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: