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 (O3MORPH)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Carlos Laino, Ph pharmacology
- 電話番号：+5493804391553
- メール：carloslaino25@gmail.com
研究場所
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La Rioja Province
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La Rioja、La Rioja Province、アルゼンチン、F5300ALR
- National University of La Rioja
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コンタクト：
- Carlos Laino
- 電話番号：0380154391553
- メール：carloslaino25@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Placebo+ Morphine group
Other: Placebo+ Morphine group
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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.
他の名前：
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実験的：Omega-3 fatty acids + Morphine group.
Omega-3 fatty acids + Morphine
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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.
他の名前：
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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 |
|---|---|---|
|
Total Morphine Requirement
時間枠：24hs
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Total morphine requirement in the 24 hours post-surgery.
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24hs
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Average Pain Score
時間枠：24 hs
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24 hs
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Average Nausea Score
時間枠：24 hs
|
24 hs
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Average Pruritus Score
時間枠：24 hs
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24 hs
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Average Vomiting Score
時間枠：24 hs
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24 hs
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Average Respiratory Depression Score
時間枠：24hs
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24hs
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Average Urinary Retention Score
時間枠：24 hs
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24 hs
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
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
- UNLAR
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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