開胸後の術後疼痛に対する超音波ガイド下のPIFBとリドカイン注入の有効性
開胸術後の急性および慢性疼痛に対する超音波ガイド下の胸筋肋間筋膜平野ブロックとリドカイン注入の有効性。前向きランダム化対照試験
Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .
調査の概要
詳細な説明
Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.
Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PSPS
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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e\EYGPT
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Banī Suwayf、e\EYGPT、エジプト
- Benisuef University 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 between 18 and 75 years.
- patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- American Society of Anesthesiologists classification of physical status < IV.
Exclusion Criteria:
- emergency surgery.
- off-pump surgery.
- redo surgery.
- ejection fraction less than 35%.
- refusal of the patient.
- known hypersensitivity to LA.
- chronic opioid use or chronic pain patient.
- psychiatric problems or communication difficulties.
- liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
- renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
- obstructive sleep apnea syndrom.
- coexisting hematologic disorders.
- pregnancy or breastfeeding.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：PIFB group
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side. |
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.
他の名前：
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アクティブコンパレータ：LIDOCAINE group
1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery. |
1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total dose of morphine in the first 24 h postoperatively.
時間枠：24 hours postoperative
|
total morphine consumed in the first 24 hour |
24 hours postoperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NRS numerical rating scale.
時間枠：24 hours post operative
|
NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief |
24 hours post operative
|
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chronic postoperative pain in 3 months after operation according to numerical rating scale
時間枠：within 3 months postoperative
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NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief |
within 3 months postoperative
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Time to rescue analgesic
時間枠：within 24 hour postoperative
|
time from extubation to the time the patiants given analgesia |
within 24 hour postoperative
|
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time to extubation
時間枠：within 24 hour post operative
|
from end of surgery to the time of extubation |
within 24 hour post operative
|
|
length of intensive care stay
時間枠：within one week
|
from end of surgery to the time of discharging to the surgical word |
within one week
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mariana A mansour, Lecturer、benisuef university hospital,Egypt
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
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