Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia

Официальное название

Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial

Обзор

Currently the prevalent approach to perioperative management of patients is ERAS (Enhanced Recovery After Surgery) concept. This approach includes numerous aspects, among which the perioperative use of multimodal analgesia takes one of the leading places. Within the ERAS guidelines all sorts of minimization of opioid analgesics use in schemes of postoperative analgesia are appreciated. Thus, new pharmacological approaches are being actively developed currently in order to achieve adequate analgesia and to minimize the use of this group of drugs. One of the most perspective trends within the multimodal analgesia concept is continuous infusion of non-steroidal anti-inflammatory drugs (NSAID). Up to date there are papers that both confirm the effectiveness of this method for maintaining adequate postoperative analgesia and show its limitations and deny the advantages of the continuous use of NSAID. Up to this time the main attention of the medical community was paid for such drugs as paracetamol and ketoprofen. Nevertheless, one of the most common and safe NSAID is ibuprofen. In spite of this, there are no studies that explore the effectiveness of the continuous infusion of this drug. Thus, the lack of even low-quality evidence led to setting up a study of effectiveness and safety of continuous infusion of ibuprofen in comparison to its bolus injection.

Вмешательства

• Препарат Ibuprofen continuous infusion
  1. The first bolus: ibuprofen 400 mg diluted in 0,9% NaCl 200 ml is intravenous injected during the first hour right after the admission to the department. The drug is injected during the first hour at the rate of 4 mg/kg/h for the ideal body weight. 2. Continuous infusion: * Ibuprofen 1200 mg diluted in 0,9% NaCl 300 ml is intravenous injected on the first day with the speed of 1 mg/kg/h (for the ideal body weight) during the remaining 23 hours. * On the second day the intravenous infusi
• Препарат Ibuprofen bolus injection
  1. The first bolus: ibuprofen 400 mg diluted in 0, 9% NaCl 200 ml is intravenous injected during the first hour right after the admission to the department. The drug is injected during the first hour at the rate of 4 mg/kg/h for the ideal body weight. 2. Bolus injection: * Every 8 hours a intravenous bolus of ibuprofen 800 mg diluted in 0,9% NaCl 200 ml is injected during 1 hour (3 boluses per day in total). * On the second day the every 8 hours intravenous bolus of ibuprofen 800 mg dilut

Первичные конечные точки

• Opioid consumption [Срок оценки: up to 28 days]

Вторичные конечные точки (1)

• Pain intensity assessment [Срок оценки: From admission to ICU until 48 hours postoperatively]

Критерии участия

Критерии включения

• Age > 18 years old
• Elective laparoscopic surgery
• General anesthesia
• Signed informed consent from the patient to participate in the study
• RASS scale from -2 to +1 on admission to a surgical department or ICU

Критерии исключения

• History of ibuprofen allergy
• Active erosive or ulcerative lesions of the gastrointestinal tract
• Chronic use of opioid analgesics or NSAIDs prior to enrollment
• Chronic kidney disease ≥ 3b stage according to the KDIGO classification
• Liver dysfunction (three times exceeding the upper reference limit of ALT or AST)
• A history of bronchial asthma
• A history of hereditary coagulopathies
• A history of use of anticoagulants

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• City Clinical Hospital named after S.S. Yudin — Moscow

Идентификаторы

NCT: NCT07070050 · CALM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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