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Набор скоро начнётся NCT07657468

Phase II, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids as an Adjunct to Morphine in Acute Postoperative Pain

Фаза II С лечением Pain Postoperative Analgesia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Omega-3 fatty acids + Morphine group, Placebo+ Morphine group.
Кому может быть актуально
Состояния в реестре: Pain Postoperative, Analgesia. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Аргентина
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a single-center, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept study to evaluate the analgesic efficacy and safety of omega-3 fatty acids as an adjunct to morphine for acute postoperative pain following laparoscopic cholecystectomy. Patients will receive either omega-3 fatty acid supplementation or a placebo before and after surgery. At the end of surgery, a loading dose of morphine of 0.04 mg/kg body weight will be administered intravenously as a bolus in both groups. The primary endpoint will be the total amount of rescue morphine used during the first 24 postoperative hours.

Подробное описание

Currently, the most widely used drugs for treating post-surgical pain are opioids, such as morphine. Morphine works primarily by activating specific opioid receptors, providing significant pain relief but also causing side effects that limit its use.

Preclinical studies in our laboratory have shown that combined treatment with morphine and omega-3 fatty acids produces an additive enhancement of morphine's analgesic effect, mediated by the opioid pathway. Furthermore, we observed that this combined treatment prevents development of tolerance to morphine's analgesic effect and reduces some of the drug's adverse effects.

In order to reduce morphine dose and decrease or avoid morphine's side effects, the present study was designed to administer omega-3 fatty acids as an adjunct to morphine for acute postoperative pain following laparoscopic cholecystectomy.

Вмешательства

  • Препарат Omega-3 fatty acids + Morphine group
    The omega-3 fatty acids will be given twice before surgery (1680 mg/day) once on the day of surgery (840 mg) with 0,04 mg/kg morphine, and twice the day after surgery (1680 mg/day). It will be administered with lunch or dinner.
  • Другое Placebo+ Morphine group
    The placebo will be given twice before surgery (1680 mg/day) once on the day of surgery (840 mg) with 0,04 mg/kg morphine, and twice the day after surgery (1680 mg/day). It will be administered with lunch or dinner.

Первичные конечные точки

  • Total Morphine Requirement [Срок оценки: 24hs]
Вторичные конечные точки (6)
  • Average Pain Score [Срок оценки: 24 hs]
  • Average Nausea Score [Срок оценки: 24 hs]
  • Average Pruritus Score [Срок оценки: 24 hs]
  • Average Vomiting Score [Срок оценки: 24 hs]
  • Average Respiratory Depression Score [Срок оценки: 24hs]
  • Average Urinary Retention Score [Срок оценки: 24 hs]

Критерии участия

Критерии включения

  • Able to provide written informed consent prior to any study procedures;
  • Able to communicate clearly with the Investigator and staff;
  • Males and females aged 18 to 65;
  • American Society of Anesthesiologists (ASA) risk class of I to II;
  • Patients with an indication for laparoscopic cholecystectomy.

Критерии исключения

  • Patients with reduced kidney function (serum creatinine level above 2 mg/dl).
  • Sensitive to local anesthetics.
  • A history of hepatic insufficiency.
  • Chronic pain.
  • Patients with diabetes.
  • Patients with Body Mass Index (BMI) greater than 35 kg/m2.
  • Daily intake of analgesics or corticosteroids.
  • Patients with Inflammatory bowel disease.
  • Chronic opioid use.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Аргентина · 1 центр
  • National University of La Rioja — La Rioja

Публикации

  • Athanasiou A, Charalambous M, Anastasiou T, Soteriades ES. Pre- and post-operative administration of omega-3 polyunsaturated fatty acids in cardiac surgery patients. A narrative review. Ann Med Surg (Lond). 2025 Mar 18;87(4):2068-2092. doi: 10.1097/MS9.0000000000003061. eCollection 2025 Apr. PMID 40212170
  • Arriaza N, Papuzinski C, Kirmayr M, Matta M, Aranda F, Stojanova J, Madrid E. Efficacy of methadone for the management of postoperative pain in laparoscopic cholecystectomy: A randomized clinical trial. Medwave. 2021 Mar 23;21(2):e8135. doi: 10.5867/medwave.2021.02.8134. English, Spanish. PMID 33905405
  • Ikeda I, Sasaki E, Yasunami H, Nomiyama S, Nakayama M, Sugano M, Imaizumi K, Yazawa K. Digestion and lymphatic transport of eicosapentaenoic and docosahexaenoic acids given in the form of triacylglycerol, free acid and ethyl ester in rats. Biochim Biophys Acta. 1995 Dec 7;1259(3):297-304. doi: 10.1016/0005-2760(95)00180-8. PMID 8541338
  • Escudero GE, Romanuk CB, Toledo ME, Olivera ME, Manzo RH, Laino CH. Analgesia enhancement and prevention of tolerance to morphine: beneficial effects of combined therapy with omega-3 fatty acids. J Pharm Pharmacol. 2015 Sep;67(9):1251-62. doi: 10.1111/jphp.12416. Epub 2015 May 25. PMID 26011306

Идентификаторы

NCT: NCT07657468 · UNLAR

Первоисточники (государственные реестры)

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