成人における橈骨遠位端骨折の観血的整復に対する腕神経叢神経ブロックと標準治療 - BLOCK試験。全国多施設ランダム化対照試験
The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark.
Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:
- A nerve block of the arm (plexus brachialis block)
- A haematoma block, which is the current standard anaesthesia in the emergency departments.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Capital Region
-
Hillerød、Capital Region、デンマーク、3400
- Copenhagen University Hospital - North Zealand Hillerød
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion Criteria:
- Patients who would never qualify for surgery according to local guidelines
- Lack of informed consent
- No Danish Central Person Register (CPR) number
- Allergies to the trial medication
- Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
- Open fractures (fracture-related wound requiring sutures)
- Other fractures on the same extremity ((NOT including distal ulna fracture(s))
- Bilateral distal radius fractures both requiring closed reduction
- Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention group
Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections. |
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block |
|
アクティブコンパレータ：Control group
Haematoma block with local anaesthetics i.e. lidocaine with adrenaline |
Participants will receive no peripheral nerve block and receive a haematoma block, with or without supplemental sedation and/or systemic analgesia for the closed reduction according to local guidelines and clinical practices |
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 |
時間枠 |
|---|---|
|
橈骨遠位端骨折手術を受けた患者の累計割合
時間枠：クローズド削減から 90 日後
|
クローズド削減から 90 日後
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite outcome of treatment related complications
時間枠：90 days after closed reduction
|
loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries (including skin injuries) related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment (including compression), pneumothorax, allergic reaction, new bone or joint injury (e.g. dislocation or fracture) after the closed reduction and/or pulmonary embolism |
90 days after closed reduction
|
|
Patient Rated Wrist Evaluation (PRWE)
時間枠：90 days after closed reduction
|
The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
90 days after closed reduction
|
|
Maximum pain score in the affected wrist during closed reduction(s)
時間枠：0-12 hours after the closed reduction
|
The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. If the patient has the closed reduction performed more than one time, the patient will be asked to report the worst pain experienced during all the attempts of a closed reduction. |
0-12 hours after the closed reduction
|
|
Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction
時間枠：0 -24 hours after closed reduction
|
The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
0 -24 hours after closed reduction
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
クローズドリダクションに使用された試行回数
時間枠：非閉鎖整復直後
|
非閉鎖整復直後
|
|
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複合副次転帰における個々の合併症の割合
時間枠：クローズド削減から 90 日後
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クローズド削減から 90 日後
|
|
|
Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction
時間枠：0-12 hours, 90 days and 12 months after closed reduction
|
The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. |
0-12 hours, 90 days and 12 months after closed reduction
|
|
Maximum pain in the affected wrist within the first 24 hours after closed reduction
時間枠：24-36 hours after the closed reduction.
|
The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable. |
24-36 hours after the closed reduction.
|
|
Proportion of patients with complex regional pain syndrome (CRPS)
時間枠：90 days and 12 months after closed reduction
|
CRPS is defined according to the Budapest Criteria |
90 days and 12 months after closed reduction
|
|
Disabilities of the Arm, Shoulder, and Hand (DASH) score
時間枠：90 days and 12 months after closed reduction
|
DASH-score is calculated from the Danish-validated translation of the DASH questionnaire |
90 days and 12 months after closed reduction
|
|
Patient Rated Wrist Evaluation (PRWE)
時間枠：12 months after closed reduction
|
PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
12 months after closed reduction
|
|
Quality of life (EQ-5D-5L) score
時間枠：90 days and 12 months after closed reduction
|
The Danish translation of the EQ-5D-5L questionnaire is used and the EQ-5D-5L-score is calculated based on the Danish EQ-5D-5L value set |
90 days and 12 months after closed reduction
|
|
Difficulty of closed reduction of the fracture
時間枠：Immediately after closed reduction
|
The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult) |
Immediately after closed reduction
|
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Discomfort related to the anaesthetic procedure
時間枠：0-12 hours after closed reduction
|
The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable |
0-12 hours after closed reduction
|
|
Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia
時間枠：24 hours after closed reduction
|
The overall satisfaction is a patient-reported outcome on a numeric rating scale from 0-10; 0=very unsatisfied, 10=very satisfied. When evaluating the treatment, the patient is specifically asked to include all elements of the treatment including: the anaesthetic (procedure and following effects), the experience during the closed reduction and the pain and general sensation in the arm/wrist in the first 24 hours after the treatment commencement. |
24 hours after closed reduction
|
|
Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction)
時間枠：10-14 days after closed reduction
|
The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
10-14 days after closed reduction
|
|
Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function
時間枠：Within 90 days after closed reduction
|
A SAE is defined as an adverse event that leads to the following incidents:
Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE. |
Within 90 days after closed reduction
|
|
Proportion of patients having one or more adverse events (AEs)
時間枠：Within 24 hours after closed reduction
|
An AE is defined as any harmful and unintended event, sign, or symptom, that appear during the trial period, regardless of whether this AE is considered related to the treatment or not. |
Within 24 hours after closed reduction
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Cecilie D Harwood, MD, PhD-fellow、Copenhagen University Hospital - North Zealand
- 主任研究者：Anne-Sofie Jellestad, MD, PhD-fellow、Copenhagen University Hospital - North Zealand
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- CTA no: 2024-512191-35-00
個々の参加者データ (IPD) の計画
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