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临床试验/NCT07625787
NCT07625787已完成不适用

EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY

Kathmandu University School of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1

研究概览

简要总结

Distal radius fractures are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. This study's goal is to assess how well the Hematoma Block (HB) reduces distal forearm fractures in a developing nation like Nepal. At a tertiary care hospital, a randomized comparative study is used. The individuals with distal forearm fractures that have been radiologically confirmed are enrolled after taking informed consent. When reducing distal forearm fractures, the patients are divided into two groups: Brachial Plexus Block (BPB group) and Hematoma Block group. We note the level of pain before, during, and after reduction using the Visual Analogue Scale (VAS) in both groups. The patient's radiological correction is assessed by Modified Sarmiento Criteria with an immediate post reduction radiograph.

Comparing Hematoma Block and Brachial Plexus Block, we can choose a definitive easy method for reduction that is easy, safe and less time consuming. Hence, the study will provide a guide for commonly occurring distal radius fracture.

Hypotheses of the Study:

Null hypothesis (Ho): There is no difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.

Ho: Safety, efficacy and quality of reduction with Hematoma block = Brachial plexus block

Alternate hypothesis (H1): There is a difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.

H1: Safety, efficacy and quality of reduction with Hematoma block ≠ Brachial plexus block

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult male or female patients in the age range of skeletally mature (18 years and above)
  • Displaced distal radius fracture, requiring manipulation
  • Only extra-articular fractures.

排除标准

  • Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures.
  • Undisplaced distal radial fractures which do not require manipulation.
  • Patients who have a history of an adverse reaction to local anesthetics.
  • Polytrauma, multiple injuries

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rohit Shrestha

Professor

Kathmandu University School of Medical Sciences

研究点 (1)

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