SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy (SERRATHOR)
SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.
Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.
The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.
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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Strasbourg、フランス、67091
- Les Hopitaux Universitaires de Strasbourg
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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
説明
Inclusion criteria:
- All patients undergoing lobectomy VATS
- Older > 18 years
- Patients who meet criteria of ASA 1 to 3 class
Exclusion criteria:
- Patient's refusal to participate in the study
- Psychiatric disorder (impossibility to collect the informed consent)
- Patient under juridical protection
- On going an other study
- Non balanced epilepsy
- 3 grade auriculo-ventricular heart block without pacing
- Severe hepatocellular insufficiency
- Anti arrhythmic treatment : class III of the Vaughan William's classification
- Pregnant patient or/and breastfeeding
- History of opioid abuse
- Allergy to local anesthetic drug or opioids
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：支持療法
- 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 |
|---|---|
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実験的：Serratus Block
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product. |
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
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プラセボコンパレーター：Placebo Block - Control Group
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product. |
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution
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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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Total intravenous morphine consumption (mg) in the PACU and department.
時間枠：24 hours
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Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.
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24 hours
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協力者と研究者
捜査官
- 主任研究者：Bob HEGER、Les Hopitaux Universitaires de Strasbourg
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
本研究に関する用語
その他の研究ID番号
- 6755
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?
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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