肩関節鏡検査を受けた患者における麻酔法による術後の回復の質の比較
肩関節鏡検査を受ける患者における麻酔法による術後の回復の質の比較：全身麻酔下での疼痛コントロールのための腕神経叢ブロックと鎮静下での外科的ブロックのための腕神経叢ブロック
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
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
-
-
Jongno-gu
-
Seoul、Jongno-gu、韓国、03080
- Seoul National University Hospital
-
-
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:
- Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery
Exclusion Criteria:
- emergency operation
- inflammation or infection at the site of nerve block administration
- inability to perform the quality of recovery questionnaire due to dementia or delirium
- severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
- contraindication to brachial plexus block
- history of hypersensitivity or side effect to ropivacaine
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 |
|---|---|
|
アクティブコンパレータ：General anesthesia
The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. |
General anesthesia with propofol, fentanyl and rocuronium for induction, and with sevoflurane for maintenance. Brachial plexus block with 0.5% ropivacaine for intra- and postoperative analgesia. |
|
実験的：Brachial plexus block
The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. |
Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol. |
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 |
|---|---|---|
|
Quality of recovery (QoR-15) at 48 hours post-surgery
時間枠：at 48 hours post-surgery
|
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150) |
at 48 hours post-surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Antiemetic administration
時間枠：rom end of surgery up to 48 hours post-surgery
|
Antiemetic administration from end of surgery up to 48 hours post-surgery |
rom end of surgery up to 48 hours post-surgery
|
|
Baseline hemidiagphramatic paralysis
時間枠：On the day of surgery, before the operation
|
Baseline hemidiagphramatic paralysis |
On the day of surgery, before the operation
|
|
Postoperative hemidiagphramatic paralysis
時間枠：Immediately after surgery
|
Postoperative hemidiagphramatic paralysis |
Immediately after surgery
|
|
Quality of recovery (QoR-15) on the day before surgery
時間枠：on the day before surgery
|
Quality of recovery (QoR-15) on the day before surgery (0-150) |
on the day before surgery
|
|
Quality of recovery (QoR-15) 24 hours post-surgery
時間枠：at 24 hours post-surgery
|
Quality of recovery (QoR-15) 24 hours post-surgery (0-150) |
at 24 hours post-surgery
|
|
Postoperative pain 1 hour post-surgery
時間枠：at 1 hour post-surgery
|
Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 1 hour post-surgery
|
|
Postoperative pain 6 hours post-surgery
時間枠：at 6 hours post-surgery
|
Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 6 hours post-surgery
|
|
Postoperative pain 12 hours post-surgery
時間枠：at 12 hours post-surgery
|
Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 12 hours post-surgery
|
|
Postoperative pain 24 hours post-surgery
時間枠：at 24 hours post-surgery
|
Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 24 hours post-surgery
|
|
Postoperative pain 48 hours post-surgery
時間枠：at 48 hours post-surgery
|
Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
at 48 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
時間枠：at 1 hour post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery |
at 1 hour post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
時間枠：at 6 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery |
at 6 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
時間枠：at 12 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery |
at 12 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
時間枠：at 24 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery |
at 24 hours post-surgery
|
|
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
時間枠：at 48 hours post-surgery
|
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery |
at 48 hours post-surgery
|
|
Rescue opioid analgesic administration
時間枠：from end of surgery up to 48 hours post-surgery
|
Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME) |
from end of surgery up to 48 hours post-surgery
|
協力者と研究者
捜査官
- 主任研究者：Hansol Kim, MD、Seoul National University Hospital
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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