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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo+ Morphine group | Placebo Comparator | Other: Placebo+ Morphine group |
|
| Omega-3 fatty acids + Morphine group. | Experimental | Omega-3 fatty acids + Morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acids + Morphine group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Morphine Requirement | Total morphine requirement in the 24 hours post-surgery. | 24hs |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score | 24 hs | |
| Average Nausea Score | 24 hs | |
| Average Pruritus Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Laino, Ph pharmacology | Contact | +5493804391553 | carloslaino25@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of La Rioja | La Rioja | La Rioja Province | F5300ALR | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40212170 | Result | 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. | |
| 33905405 | Result |
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|
| Placebo+ Morphine group | Other | 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. |
|
|
| 24 hs |
| Average Vomiting Score | 24 hs |
| Average Respiratory Depression Score | 24hs |
| Average Urinary Retention Score | 24 hs |
| 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. |
| 8541338 | Result | 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. |
| 26011306 | Result | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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