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临床试验/NCT07183904
NCT07183904已完成不适用

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

Hospital Universitario 12 de Octubre2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
Pain Intensity During Closed Reduction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Pain Intensity During Closed Reduction

时间窗: During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting).

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.

次要结局

  • 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).)

研究者

发起方
Hospital Universitario 12 de Octubre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Antonio Guerrero Serrano

Dr. (Orthopaedic Surgeon)

Hospital Universitario 12 de Octubre

研究点 (2)

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