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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Madona M Noman, MD
- Telefonní číslo: 201006265867
- E-mail: madonamisheal90@yahoo.com
Studijní záloha kontaktů
- Jméno: Romany G Gendy, MD
- Telefonní číslo: 201229869146
- E-mail: romanygergis@aun.edu.eg
Studijní místa
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Asyut, Egypt
- South Egypt Cancer Institute, Assiut University, Egypt
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Kontakt:
- Madona M Noman, MD
- Telefonní číslo: 201006265867
- E-mail: madonamisheal90@yahoo.com
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Quality of Recovery-15 (QoR-15) score
Časové okno: 24 hours postoperatively
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Postoperative Opioid Consumption
Časové okno: 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
Časové okno: 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)
Časové okno: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Madona M Noman, MD, Assiut University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Rány a zranění
- Pooperační komplikace
- Patologické procesy
- Chemicky indukované poruchy
- Otrava
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest, pooperační
- Kousnutí a bodnutí
- Sloučeniny síry
- Organické chemikálie
- Polycyklické sloučeniny
- Anilides
- Amidy
- Anilinové sloučeniny
- Aminy
- Anorganické chemikálie
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Steroidy, fluorované
- Kyseliny síry
- Těhotenství
- Sírany
- Kyseliny sírové
- Sloučeniny hořčíku
- Dexamethason
- Bupivakain
- Síran hořečnatý
Další identifikační čísla studie
- SECI-IRB 18-2026-849
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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