Efficacy and Safety of Hematoma Block Versus Brachial Plexus Block for Closed Reduction of Extra-Articular Distal Radius Fracture: A Prospective Study
EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bagmati
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Dhulikhel、Bagmati、尼泊尔、45200
- Dhulikhel Hospital, Kathmandu University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Brachial Plexus Block
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
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Ultrasound-guided regional anesthesia administered by anesthesiology personnel
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有源比较器:Hematoma Block
Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.
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Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Severity Assessed by Visual Analogue Scale (VAS)
大体时间:1 year
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Pain severity during fracture reduction will be assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Pain scores will be recorded prior to, during, and immediately following fracture reduction.
Higher scores indicate worse pain severity.
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1 year
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Quality of Fracture Reduction Assessed by Plain Radiographic Parameters
大体时间:1 year
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Quality of reduction following fracture manipulation will be assessed using plain radiographs in posteroanterior (PA) and lateral views.
Radiographic parameters include ulnar variance (mm), radial length (mm), radial tilt (degrees), and dorsal/palmar tilt (degrees).
Measurements will be compared between hematoma block and brachial plexus block groups.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Procedure-Related Complications
大体时间:1 year
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Complications related to fracture reduction or anesthesia technique will be recorded during hospital stay and follow-up.
Complications may include neurovascular injury, compartment syndrome, local anesthetic-related adverse events, infection, or failure of reduction.
Outcome will be reported as number and percentage of participants experiencing complications.
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1 year
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合作者和调查者
出版物和有用的链接
一般刊物
- Nho JH, Jang BW, An CY, Yoo JH, Song S, Cho HB, Kim SH, Kim SI, Jung KJ, Kim B. General versus Brachial Plexus Block Anesthesia in Pain Management after Internal Fixation in Patients with Distal Radius Fracture: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jul 27;19(15):9155. doi: 10.3390/ijerph19159155.
- Lari A, Jarragh A, Alherz M, Nouri A, Behbehani M, Alnusif N. Circumferential periosteal block versus hematoma block for the reduction of distal radius and ulna fractures: a randomized controlled trial. Eur J Trauma Emerg Surg. 2023 Feb;49(1):107-113. doi: 10.1007/s00068-022-02078-8. Epub 2022 Aug 18.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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