Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
調査の概要
詳細な説明
Background Several studies, including a metanalysis, have demonstrated that intraperitoneal local anaesthetic (IP LA) during elective laparoscopic cholecystectomy (el-LC) decreases post operative pain. None have explored the efficacy of IP LA at emergency laparoscopic cholecystectomy (em-LC). A longer operation duration, greater frequency of washing and the inflammation associated with cholecystitis or pancreatitis are a few reasons why it cannot be assumed that a benefit in pain scores will be seen in em-LC with IP LA. This study assesses the efficacy of IP LA used in patients undergoing em-LC.
Methods Double blind randomised sham controlled trial of 42 consecutive subjects undergoing em- LC.
IP-LA was delivered by a combination of direct injection to the diaphragmatic and topical wash over the liver/gall bladder with bupivacaine or sham depending upon allocation. The primary outcome was VAS pain scores on the ward. Secondary outcomes included VRS pain scores in theatre recovery, analgesic use, physiological observations, time to eating and ambulation and length of postoperative stay.
Results One patient had a procedure converted to open and was excluded. There was no significant difference in pain scores on the ward or in theatre recovery. Analgesic use, respiratory rate, oxygen saturation, duration to ambulation, eating, satisfaction scores and time to discharge were comparable between the groups.
Conclusions Intraperitoneal LA during em-LC does not influence post-operative pain. Other modalities of analgesia should be explored as well as decreasing the interval between diagnosis of acute admission and em-LC.
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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Warwickshire
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Coventry、Warwickshire、イギリス、CV2 2DX
- University Hospitals Coventry and Warwickshire
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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:
- patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis
Exclusion Criteria:
- patients undergoing planned elective cholecystectomy
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ:Saline sham injection
Sham wash and injection with normal saline (09%)
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sodium chloride 0.9% solution
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アクティブコンパレータ:Bupivacaine
Bupivacaine injection/wash treatment arm
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0.25% 20ml administered intraperitoneal
他の名前:
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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 |
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VAS pain score
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二次結果の測定
結果測定 |
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VRS pain score
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Satisfaction score (VAS)
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Physiological observations - respiratory rate, oxygen saturation
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Analgesic use post operation
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協力者と研究者
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
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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