Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries
Evaluation of Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries: A Prospective Randomized Controlled Study
The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection
調査の概要
状態
詳細な説明
Inguinal lymph node dissection is the surgical removal of lymph nodes from your groin (where your legs meet your lower abdomen). Inguinal lymph node dissection is used to see if cancer has spread from certain areas (usually your penis, vulva, anus or the skin on your legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will come back in the future and help providers understand the options for treating your cancer and help you know what to expect.
Transversalis fascia plane block (TFPB) used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block.
The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified.
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 S Abdelgalil, MD
- 電話番号：00201098426689
- メール：ahmed.salah@nci.cu.edu.eg
研究場所
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-
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Cairo、エジプト、12613
- 募集
- Cairo University
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コンタクト：
- Ahmed S Abdelgalil, MD
- 電話番号：00201098426689
- メール：ahmed.salah@nci.cu.edu.eg
-
-
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) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Exclusion Criteria:
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：Group 1
Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. |
Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. |
|
実験的：Group 2
Patients will receive ultrasound guided transversalis fascia plane block. |
Patients will receive ultrasound guided transversalis fascia plane block.
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 |
|---|---|---|
|
Degree of pain
時間枠：24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). |
24 hours postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total fentanyl consumption
時間枠：Intraoperatively
|
When elevation of Heart rate (HR) or mean arterial blood pressure (MAP) ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg. |
Intraoperatively
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Total opioid consumption
時間枠：24 hours postoperatively
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The patients will be observed in the postoperative care unit for 2 h, and rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 h will be recorded for every patient. |
24 hours postoperatively
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Mean arterial pressure
時間枠：24 hours postoperatively
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Mean arterial pressure will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively. |
24 hours postoperatively
|
|
Heart rate
時間枠：24 hours postoperatively
|
Heart rate will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively. |
24 hours postoperatively
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Incidence of complications
時間枠：24 hours postoperatively
|
Incidence of complications such as hemodynamic instability, nausea, vomiting, failed block, unintentional intravascular injection of local anesthesia and local anesthetic toxicity will be recorded |
24 hours postoperatively
|
協力者と研究者
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
- 04-2026-300865
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
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共有時間枠
After the end of study for one year.
IPD 共有アクセス基準
The data will be available upon a reasonable request from the corresponding author.
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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