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
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Bagmati
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Dhulikhel、Bagmati、ネパール、45200
- Dhulikhel Hospital, Kathmandu University Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Severity Assessed by Visual Analogue Scale (VAS)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Procedure-Related Complications
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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