TAP Block for Open Radical Prostatectomy.
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.
調査の概要
状態
詳細な説明
Open prostatectomy is a surgical procedure performed by urologists to excise the prostate. This is achieved by a 10-cm vertical incision starting below the umbilicus and reaching the pubic area. Patients are hospitalized for 3-4 days: one of the criteria for safe discharge includes Visual Analogue Scale (VAS) for pain below 3 at rest. For postoperative pain control, patients receive patient-controlled opioid analgesia (PCA) with morphine. The average amount of morphine used in the first 24 h varies between 30 and 50 mg. Although this technique is widely used, side effects (sedation, ileus, pruritus) are commonly encountered with opioid administration. Thus alternative analgesic techniques such as epidural analgesia and wound infiltration have been used with some success. However adverse events have also been reported with these techniques (lower limb motor block with epidural; infection wound infiltration).
In the last 10 years, a new technique, the transversus abdominis plane (TAP) block, which anesthetizes the thoracolumbar nerves (intercostal, subcostal and first lumbar nerves), has been described. The thoracolumbar nerves provide sensory innervation to the anterolateral abdominal wall. The traditional technique for TAP blocks is performed with a blunt needle in the Triangle of Petit. The latter is delineated caudally by the iliac crest, posteriorly by the latissimus muscle and anteriorly by the external oblique. Two distinct pops can be felt as the needle crosses the fascial extensions of the external oblique and the internal oblique muscle, respectively. Thus the second pop usually signifies that the needle tip has reached the TAP. Although the traditional technique has been used to provide postoperatively analgesia for bowel surgery, hysterectomy and Cesarian Section, the position of the Triangle of Petit varies greatly thus making it difficult to palpate in obese patients. In 2007, there was a study describing an ultrasound-guided technique for TAP blocks: these authors advocated using ultrasonography to locate the TAP along the mid-axillary line above the iliac crest. This ultrasound-guided technique has been subsequently used to provide postoperative analgesia for laparoscopic cholecystectomy, appendicectomy and Cesarian Section. This technique has been shown to spare opioids in the postoperative period therefore facilitating an accelerated discharge and superior pain relief.
In our institution, the TAP block, either as a single shot or as a continuous catheter infusion, is used for abdominal and urological surgery when epidural blockade is not feasible.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Quebec
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Montreal、Quebec、カナダ、H3G1A4
- McGill University Health Centre, Montreal General Hospital
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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:
- Age: 18 years and over
- ASA class 1, 2
- Elective open radical prostatectomy
Exclusion Criteria:
- Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range
- Any chronic use of opioid analgesic
- Morbid obesity (BMI>40)
- History of allergic reactions to any of the study medications and the medications used for the trial
- Pregnancy
- Previous abdominal surgery
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: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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プラセボコンパレーター:Control
group A (control) will receive a bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side) via both TAP catheters.The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
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A bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side.
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
他の名前:
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実験的:TAP
group B (TAP) will receive a bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side) via TAP catheters.
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
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A bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side).
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
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 |
時間枠 |
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Postoperative morphine consumption
時間枠:at 24 hour after surgery
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at 24 hour 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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Incidence of nausea and vomiting
時間枠:at 2, 12, 24 and 48 hour after surgery
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at 2, 12, 24 and 48 hour after surgery
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VRS for pain at rest, during ambulation and coughing
時間枠:at 2, 12, 24 and 48 hour after surgery
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at 2, 12, 24 and 48 hour after surgery
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Assessment of recovery
時間枠:at 24 hours after the surgery and every 24 hours until patients are discharged.
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Assessment of recovery (two-minute walking test, Miles scale) and time out of bed (sitting or walking will be measured every day until hospital discharge.
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at 24 hours after the surgery and every 24 hours until patients are discharged.
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Postoperative morphine consumption
時間枠:at 2, 12 and 48 hours after surgery
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at 2, 12 and 48 hours after surgery
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協力者と研究者
捜査官
- 主任研究者:Franco Carli, Professor、McGill University Healt Centre, Department of Anesthesia
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GEN-10-012
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