External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
調査の概要
状態
詳細な説明
Paediatric nerve blocks are increasingly recognized as new standard for managing pain in children. The advantages of regional anesthesia in this population include enhanced operating conditions, expedited recovery of bowel function, and reduced postoperative pain.
The caudal epidural block remains the most used method; however, the external oblique intercostal block, a novel technique involves administering local anesthesia deep to the external oblique muscle at the sixth intercostal space, thereby blocking thoracoabdominal nerves from T6 to T10. This technique offers several advantages, including straightforward anatomy, a single muscle strip that is easily identifiable even in obese patients, a bony backstop, and an easily expandable fascial plane that can accommodate a catheter.
The erector spinae plane block involves injecting local anesthetic into the fascial plane beneath the erector spinae muscle at the tip of the vertebral transverse process. This allows the local anesthetic to spread in the craniocaudal fascial plane.
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：Belal M Hassan, MBBCH
- 電話番号：00201091397908
- メール：Belal.bakr1420@alexmed.edu.eg
研究場所
-
-
-
Alexandria、エジプト、21526
- 募集
- Alexandria University
-
コンタクト：
- Belal M Hassan, MBBCH
- 電話番号：00201091397908
- メール：Belal.bakr1420@alexmed.edu.eg
-
副調査官：
- Wafaa M Shafshak, MD
-
副調査官：
- Ola M Zanaty, MD
-
副調査官：
- Mohamed W Nassar, MD
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged between 6 and 12 years of both sex.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Patients undergoing upper abdominal surgeries involving upper abdominal incisions.
Exclusion Criteria:
- Guardian refusal.
- Allergy to local anesthetics.
- Surgical procedures exceeding 3 hours.
- Infection at the area planned for the block injection.
- Prolonged opioid medication.
- Patients preoperatively medicated by Beta blockers
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 |
|---|---|
|
実験的：Group I
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
|
実験的：Group II
Patients will receive ultrasound-guided erector spinae plane block.
|
Patients will receive ultrasound-guided erector spinae plane block.
|
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 |
|---|---|---|
|
Degree of pain
時間枠：12 hours after surgery
|
Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations. The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain". Children are instructed to select the face that most accurately reflects their current pain level. The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity. |
12 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate
時間枠：Every 15 minutes intraoperative
|
Heart rate will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Mean arterial blood pressure
時間枠：Every 15 minutes intraoperative
|
Mean arterial blood pressure will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Peripheral oxygen saturation
時間枠：Every 15 minutes intraoperative
|
Peripheral oxygen saturation will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Duration of analgesia
時間枠：12 hours after surgery
|
Duration of analgesia will be recorded from block completion till first postoperative rescue analgesia requirement.
|
12 hours after surgery
|
|
Total rescue analgesia requirement
時間枠：12 hours after surgery
|
In Faces Pain Scale score-revised, cut of points for analgesic requirement is ≧ 4, rescue analgesia will be administered in the form of nalbuphine 0.1 mg/kg, with a maximum dose of 0.2 mg/kg.
|
12 hours after surgery
|
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Incidence of complications
時間枠：12 hours after surgery
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Incidence of complications including hematomas block failure, intravascular injection, pneumothorax or injection into the peritoneal cavity, with associated risks of damage to bowel and other abdominal viscera at the block site will be recorded.
|
12 hours after surgery
|
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
その他の研究ID番号
- 00012098 (0109306)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
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