Effect of Transversus Abdominis Plane (TAP) Block Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery.
Effect of Magnesium Sulfate Added to Dexamethasone-Augmented Ultrasound-Guided Transversus Abdominis Plane (TAP) Block on Early Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery: A Prospective Randomized Double-Blind Controlled Trial
This prospective, randomized, double-blind, controlled clinical trial is designed to evaluate whether adding magnesium sulfate to a dexamethasone-augmented, ultrasound-guided transversus abdominis plane (TAP) block improves early postoperative recovery and analgesia in adult patients undergoing open abdominal cancer surgery.
A total of 72 participants will be allocated into two groups. Both groups will receive a standard TAP block using bupivacaine and dexamethasone, while the intervention group will additionally receive magnesium sulfate.
The primary outcome of the study is the early quality of recovery assessed at 24 hours postoperatively. Secondary outcomes include postoperative pain scores, total opioid consumption, time to first rescue analgesia, the incidence of postoperative nausea and vomiting, patient satisfaction, block-related complications, intraoperative opioid requirements, hemodynamic parameters, and the incidence of chronic postoperative pain assessed through six months of follow-up.
調査の概要
状態
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：Madona M Noman, MD
- 電話番号：201006265867
- メール：madonamisheal90@yahoo.com
研究連絡先のバックアップ
- 名前：Romany G Gendy, MD
- 電話番号：201229869146
- メール：romanygergis@aun.edu.eg
研究場所
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Asyut、エジプト
- South Egypt Cancer Institute, Assiut University, Egypt
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コンタクト：
- Madona M Noman, MD
- 電話番号：201006265867
- メール：madonamisheal90@yahoo.com
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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:
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•Age 18-70 years.
- ASA physical status I-III.
- Scheduled for elective abdominal cancer surgery.
- Able to understand the study protocol and complete the QoR-15 questionnaire. Provided written informed consent
Exclusion Criteria:
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• Patient refusal.
- Allergy to local anesthetics, dexamethasone, magnesium sulfate, or study medications.
- Coagulopathy or anticoagulant therapy.
- Local infection at the injection site.
- Severe hepatic or renal impairment.
- Neuromuscular disorders.
- Chronic opioid use or chronic pain syndromes.
- Pregnancy or lactation in females .
- BMI >35 kg/m².
- Cognitive impairment or inability to communicate effectively.
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：支持療法
- 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 |
|---|---|
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アクティブコンパレータ：Group D
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml) and diluted to 40ml with normal saline (18ml),20ml per side. |
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg total volume 40ml ,20ml volume per side in both groups. Dexamethasone 8 mg will be administered as an adjunct to TAP block in both groups |
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実験的：Group DM
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml),250mg magnesium sulfate (2.5ml) and diluted to 40ml with normal saline (15.5ml),20ml per side |
Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg total volume 40ml ,20ml volume per side in both groups. Dexamethasone 8 mg will be administered as an adjunct to TAP block in both groups Magnesium sulfate 250 mg will be administered as an adjunct to TAP block in DM group only |
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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Quality of Recovery-15 (QoR-15) score
時間枠：24 hours postoperatively
|
The Quality of Recovery-15 questionnaire will be used to assess the quality of postoperative recovery 24 hours after surgery, evaluating five dimensions: physical comfort, emotional state, psychological support, physical independence, and pain, resulting in a total score ranging from 0 to 150 (higher scores indicate better recovery). |
24 hours postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Postoperative Opioid Consumption
時間枠：During the first 24 hours postoperatively
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Measuring the total morphine consumption required by the patient as rescue analgesia. |
During the first 24 hours postoperatively
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Time to First Request for Rescue Analgesia
時間枠：Within the first 24 hours postoperatively
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Recording the duration from the end of surgery until the patient first requests rescue analgesia (when Visual Analogue Scale (VAS)is 4 or more). |
Within the first 24 hours postoperatively
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Mean Arterial Pressure (MAP)
時間枠：At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
|
Assessing Mean Arterial Pressure (MAP) values |
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
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Chronic Postoperative Pain
時間枠：Through 6 months postoperatively
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Assessing the presence or absence of chronic postoperative pain and its intensity using the Visual Analogue Scale (VAS)ranging from 0 (no pain) to 10 (worst imaginable pain)minimum value of 0, maximum value of 10, where higher scores mean a worse outcome. |
Through 6 months postoperatively
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Postoperative Pain Intensity
時間枠：At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.]
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Evaluating postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). |
At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.]
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Patient Satisfaction
時間枠：At 24 hours postoperatively
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Evaluating patient satisfaction with postoperative pain management using a 5-point Likert scale (ranging from very dissatisfied to very satisfied)(minimum value of 1, maximum value of 5, where higher scores mean a better outcome). |
At 24 hours postoperatively
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TAP Block-Related Complications and Adverse Effects
時間枠：Intraoperatively and throughout the 24-hour postoperative period
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Evaluating the overall incidence of any block-related complications or adverse events (including block failure, local anesthetic systemic toxicity, hematoma, infection, pneumothorax, nerve injury, or magnesium-related side effects), reported as the percentage of affected patients out of the total study population |
Intraoperatively and throughout the 24-hour postoperative period
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Intraoperative Fentanyl Requirements
時間枠：Intraoperatively (during the surgical procedure)
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Measuring the total intraoperative consumption of fentanyl. |
Intraoperatively (during the surgical procedure)
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Postoperative Nausea
時間枠：During the first 24 hours postoperatively
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Recording the incidence of postoperative nausea episodes |
During the first 24 hours postoperatively
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Postoperative Vomiting
時間枠：During the first 24 hours postoperatively
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Recording the incidence of postoperative vomiting episodes. |
During the first 24 hours postoperatively
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Heart rate
時間枠：At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
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Assessing heart rate values. |
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
|
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Oxygen Saturation (SpO2)
時間枠：At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
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Assessing peripheral oxygen saturation levels. |
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Madona M Noman, MD、Assiut University
出版物と役立つリンク
一般刊行物
- Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
- Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.
- Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Norman G. Likert scales, levels of measurement and the "laws" of statistics. Adv Health Sci Educ Theory Pract. 2010 Dec;15(5):625-32. doi: 10.1007/s10459-010-9222-y. Epub 2010 Feb 10.
- Almarakbi WA, Kaki AM. Addition of dexmedetomidine to bupivacaine in transversus abdominis plane block potentiates post-operative pain relief among abdominal hysterectomy patients: A prospective randomized controlled trial. Saudi J Anaesth. 2014 Apr;8(2):161-6. doi: 10.4103/1658-354X.130683.
- Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg. 2011 Jun;112(6):1504-8. doi: 10.1213/ANE.0b013e3182159bf8. Epub 2011 Apr 5.
- Liu X, Song T, Chen X, Zhang J, Shan C, Chang L, Xu H. Quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal surgeries: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Mar 2;20(1):53. doi: 10.1186/s12871-020-00967-2.
- Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.
- Tucker DR, Noga HL, Lee C, Chiu DS, Bedaiwy MA, Williams C, Allaire C, Talhouk A, Yong PJ. Pelvic pain comorbidities associated with quality of life after endometriosis surgery. Am J Obstet Gynecol. 2023 Aug;229(2):147.e1-147.e20. doi: 10.1016/j.ajog.2023.04.040. Epub 2023 May 4.
- Tao S, Ning M, Lu Y, Hu C, Chen L, Yang Y. Transversus abdominis plane block improves postoperative recovery following cesarean delivery under general anesthesia: A propensity score matched retrospective cohort study. Int J Gynaecol Obstet. 2024 Feb;164(2):641-649. doi: 10.1002/ijgo.15011. Epub 2023 Jul 26.
- Prabhakar P, Ganapathi HP, Suresh V, Farias A, Manoharan M. Surgeon administered transversus abdominis plane block: anatomic principles and technique. J Robot Surg. 2023 Aug;17(4):1193-1205. doi: 10.1007/s11701-023-01535-9. Epub 2023 Jan 29.
- van den Beukel BAW, de Ree R, van Goor H, van der Wal SEI, Ten Broek RPG. Analgesia in patients with adhesion-related chronic abdominal and pelvic pain after surgery: a systematic review. Acta Chir Belg. 2022 Oct;122(5):303-311. doi: 10.1080/00015458.2021.1881336. Epub 2022 Jul 18.
研究記録日
主要日程の研究
研究開始 (推定)
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
- SECI-IRB 18-2026-849
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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