Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

Официальное название

Evaluation of Effectiveness of Ultrasound-Guided Modified Thoracoabdominal Nerve Plane Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia Management in Patients Undergoing Laparoscopic Sleeve Gastrectomy Operation

Обзор

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.

Подробное описание

LSG is defined as first-line bariatric surgery for patients at high surgical risk with better surgical outcomes. Effective postoperative pain management is essential for early mobilization, and reduction of the risk of morbidity and mortality. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications such as atelectasis and impaired alveolar gas exchange, apnea; postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Additionally, reducing postoperative opioid consumption helps to provide hemodynamic stability and promote early mobilization. Studies are showing M-TAPA block to be effective for postoperative analgesia for abdominal surgeries, and some studies continued comparing its effect in laparoscopic sleeve gastrectomy with other plane blocks. There are also case reports showing the effectiveness of the M-TAPA block in LSG patients. M-TAPA block's effect on LSG patients has not been studied yet. The investigators hypothesize that the M-TAPA block performed in patients undergoing laparoscopic sleeve gastrectomy would reduce opioid consumption in the first 24-hour period after surgery.

Вмешательства

• Процедура M-TAPA block
  After the wound closure is completed and the patient is still under genaral anesthesia the M-TAPA block ill be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG
• Процедура Postoperative pain management
  ibuprofen 400mg (Ibuprofen-PF®) intravenous (IV), and tramadol (Contramal®) 100 mg IV will be administered to all patients 20 minutes before wound closure. After surgery, Ibuprofen 400 mg will be given three times a day. A patient-controlled analgesia (PCA) system containing 10 mcg/ml fentanyl will be provided to all patients without continuous infusion. Patients can administer boluses of 0.35 mcg/kg with a 15-minute lockout period and a maximum dose of 100 mcg per hour. Another anesthesiologist

Первичные конечные точки

• Opioid consumption [Срок оценки: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours]

Вторичные конечные точки (3)

• Pain scores [Срок оценки: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours]
• Need for rescue analgesia (tramadol) [Срок оценки: Postoperative 24-hour period]
• Adverse events [Срок оценки: Postoperative 24-hour period]

Критерии участия

Inclusion Criteria: American Society of Anesthesiologists (ASA) classification II- III Patients Scheduled for LSG under general anesthesia

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Exclusion Criteria: Patients

• with a history of bleeding diathesis,
• receiving anticoagulant treatment,
• with allergies or sensitivity to drugs used,
• with an infection on the puncture site
• with a history of alcohol or drug addiction,
• with congestive heart failure
• with liver or kidney disease
• who do not accept the procedure or participate in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University Mega Hospital Complex — Istanbul

Публикации

• Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001. PMID 21516915
• Jackson TD, Hutter MM. Morbidity and effectiveness of laparoscopic sleeve gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity. Adv Surg. 2012;46:255-68. doi: 10.1016/j.yasu.2012.05.002. PMID 22873044
• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. PMID 18443635
• Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available. PMID 30639940
• Ciftci B, Gungor H, Alver S, Akin AN, Ozdenkaya Y, Tulgar S. Clinical Experience for Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Five Patients. Dermatomal Evaluation and Application of Different Volumes: A Case Series and Review of Literature. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):354-357. doi: 10.4274/TJAR.2022.221042. PMID 37587679
• Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available. PMID 31212124

Идентификаторы

NCT: NCT06515691 · Medipol Hospital 3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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