臍上手術後の術後鎮痛のための脊柱起立面ブロック対直腸シースブロック
脊柱起立面ブロックは成人患者の臍上手術後の術後鎮痛に直腸シースブロックよりも効果的か
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Ahmed M Shaat, MD
- 電話番号:00201223482709
- メール:ahmedshaat99@gmail.com
研究場所
-
-
El-Beheira
-
Damanhūr、El-Beheira、エジプト
- 募集
- Damanhour Teaching Hospital
-
コンタクト:
- Ahmed M Shaat, MD
- 電話番号:00201223482709
- メール:ahmedshaat99@gmail.com
-
-
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:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
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:ダブル
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:Group E (n=30)
Erector Spinae Plane Block |
Postoperative Bilateral Ultrasound-guided ESPB |
|
アクティブコンパレータ:Group R (n=30)
Rectus Sheath Block |
Postoperative Bilateral Ultrasound-guided RSB |
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 |
|---|---|---|
|
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
時間枠:24 hours after block performance
|
The time interval between the block performance and the first request of postoperative analgesia |
24 hours after block performance
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
時間枠:24 hours after block performance
|
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance |
24 hours after block performance
|
|
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
時間枠:24 hours after block performance
|
The total dose of the rescue analgesic consumed in the first 24 hours after block performance |
24 hours after block performance
|
|
Number of participants and Rate of Postoperative Complications
時間枠:24 hours after block performance
|
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax |
24 hours after block performance
|
協力者と研究者
捜査官
- 主任研究者:Ahmed M Shaat, MD、Damanhour Teaching Hospital
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
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