Continuous Wound Infusion in Lumbar or Thoracic Surgery
Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Rhone Alpes
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Grenoble、Rhone Alpes、フランス、38000
- University Hospital, Departement of Anesthesia and Intensive Care
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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
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
- beneficiary of social security
Exclusion Criteria:
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
- inability to comply to protocol requirements
- psychiatric disorders or cognitive disabilities
- chronic pain or long term opioids consumption
- diabetes
- obesity (BMI > 30)
- pregnancy or lactation
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 |
|---|---|
|
実験的:ropivacaine 0.2%, wound infusion
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wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
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|
プラセボコンパレーター:saline solution 0.9%, wound infusion
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wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
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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 |
時間枠 |
|---|---|
|
morphine consumption
時間枠:48 hours after surgery
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48 hours after surgery
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
number of patients in need of morphine in post surgery monitoring room
時間枠:1 hour after surgery
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1 hour after surgery
|
|
morphine consumption in post surgery monitoring room
時間枠:1 hour post surgery
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1 hour post surgery
|
|
consumption of morphine
時間枠:72 hours after surgery
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72 hours after surgery
|
|
global self appreciation of pain management
時間枠:at 72 hours
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at 72 hours
|
|
Time required for post surgery functional recovery
時間枠:participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
Adverse effects of morphine
時間枠:72 hours after surgery
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72 hours after surgery
|
|
hospitalization delay
時間枠:participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
asked bolus divided by delivered bolus
時間枠:until 72 hours after surgery
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until 72 hours after surgery
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|
Score for pain intensity
時間枠:until 72 hours after surgery
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until 72 hours after surgery
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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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。