Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy (ISB-ROOT)
Does the Injection Site of Local Anesthetic Around the C5-C7 Nerve Roots Affect Block Success and Complication Rates During Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy?
調査の概要
詳細な説明
Patients scheduled for elective shoulder arthroscopy under general anesthesia will be randomly assigned to one of two ultrasound-guided interscalene block techniques. In one group, the local anesthetic will be injected between the C5-C7 nerve roots and the anterior scalene muscle. In the other group, the injection will be performed between the C5-C7 nerve roots and the middle scalene muscle. The same local anesthetic solution, volume, and concentration will be used in both groups.
Block success, postoperative pain control, opioid consumption, diaphragmatic movement assessed by ultrasonography, and block-related complications including vascular puncture, Horner syndrome, hoarseness, dyspnea, nausea, vomiting, and prolonged motor block will be recorded and compared between the groups.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hakan Emirkadı, MD
- 電話番号：+905322609367
- メール：hemirkadi@gmail.com
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34668
- Sultan Abdulhamid Han Training and Research Hospital
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コンタクト：
- Hakan drhemirkadi
- 電話番号：05322609367
- メール：hemirkadi@gmail.com
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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:
Adults aged 18 years or older. ASA physical status I-III. Scheduled for shoulder arthroscopy under general anesthesia with a planned ultrasound-guided interscalene block for postoperative analgesia.
Able to provide written informed consent. Normal coagulation parameters and no antithrombotic therapy. No infection or anatomical abnormality at the injection site. No known allergy to local anesthetics. No contralateral diaphragmatic paralysis or pneumothorax. No dyspnea and adequate pulmonary function.
Exclusion Criteria:
Age younger than 18 years or ASA physical status IV. Antithrombotic therapy or abnormal coagulation parameters. Infection or anatomical abnormality at the injection site. Known allergy to local anesthetics. Contralateral diaphragmatic paralysis or history of pneumothorax. Dyspnea. Refusal to undergo interscalene block.
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：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：Anterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.
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Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia.
Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
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実験的：Posterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle.
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Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia.
Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
|
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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Postoperative Analgesic Efficacy
時間枠：12 hours after surgery
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Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
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12 hours after surgery
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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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Time to First Rescue Analgesic
時間枠：12 hours after surgery
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Time from the end of surgery to first rescue analgesic administration.
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12 hours after surgery
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Hemidiaphragmatic Paralysis
時間枠：Before block and 2 hours after surgery
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Presence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
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Before block and 2 hours after surgery
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Block-Related Complications
時間枠：During block placement and within 12 hours after surgery
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Incidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
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During block placement and within 12 hours after surgery
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Block Duration
時間枠：12 hours after surgery
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Duration of sensory and motor block recorded during postoperative follow-up.
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12 hours after surgery
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協力者と研究者
捜査官
- 主任研究者：Tuna Erturk, MD、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
研究記録日
主要日程の研究
研究開始 (推定)
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
- 21-19
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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