Continuous ESP Block in Patients Undergoing CABG Surgery.
Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.
調査の概要
状態
条件
詳細な説明
All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.
All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：JOAO ALBERTO PASTOR de OLIVEIRA, MD
- 電話番号：+5511991700431
- メール：joaoalbertopastor@yahoo.com.br
研究場所
-
-
São Paulo
-
São Paulo、São Paulo、ブラジル
- 募集
- InCor
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Consent to the free and informed consent term.
- Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
- Preserved left ventricular global function (LVEF > 50%).
Exclusion Criteria:
- Moderate or severe valvular dysfunction.
- Previous anterior sternotomy.
- Known allergy to the study drugs.
- Complications during catheter insertion or block placement.
- Pre-existing diagnosed chronic pain under treatment.
- Concomitant use of drugs with a long half-life (induction and anesthetic maintenance doses will be standardized; patients taking medications with a long half-life are excluded to prevent bias in outcome assessment).
- Concomitant administration of Magnesium Sulfate.
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 |
|---|---|
|
アクティブコンパレータ：ESP Block Ropivacaine PCA group
Local anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump.
Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing.
|
Bilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL).
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
|
|
プラセボコンパレーター：ESP Block placebo PCA group
Group that will serve as a comparison for blockade with analgesia.
That is, this group had received a placebo solution.
Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side).
After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger.
|
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator.
|
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 |
|---|---|---|
|
Total morphine consumption
時間枠：From surgery completion up to postoperative day 5
|
Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record.
All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents
|
From surgery completion up to postoperative day 5
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Chronic pain scores at 30 days
時間枠：30 days after intervention.
|
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
|
30 days after intervention.
|
|
Chronic pain scores at 180 days
時間枠：180 days after intervention.
|
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
|
180 days after intervention.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 29585120.1.0000.0068
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
米国で製造され、米国から輸出された製品。
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