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

NCT07657468 | Not Yet Recruiting Phase 2

• 1 other identifier: UNLAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Postoperative; Analgesia

Keywords

analgesia; post-operation pain; analgesic adjunct; morphine reduction; omega-3 fatty acids; lapararoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Total Morphine Requirement

  Total morphine requirement in the 24 hours post-surgery.

  24hs

Secondary Outcomes (6)

• Average Pain Score

  24 hs

• Average Nausea Score

  24 hs

• Average Pruritus Score

  24 hs

• Average Vomiting Score

  24 hs

• Average Respiratory Depression Score

  24hs

Study Arms (2)

Placebo+ Morphine group

PLACEBO COMPARATOR

Other: Placebo+ Morphine group

Other: Placebo+ Morphine group

Omega-3 fatty acids + Morphine group.

EXPERIMENTAL

Omega-3 fatty acids + Morphine

Drug: Omega-3 fatty acids + Morphine group

Interventions

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.

Also known as: Active treatment for post-operative pain

Omega-3 fatty acids + Morphine group.

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.

Also known as: Post-operative placebo for pain

Placebo+ Morphine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of La Rioja: lead

Study Sites (1)

National University of La Rioja

La Rioja, La Rioja Province, F5300ALR, Argentina

Location

Related Publications (4)

• 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 RESULT

• 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 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.

  PMID: 8541338 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.

  PMID: 26011306 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Carlos Laino, Ph pharmacology

CONTACT

+5493804391553; carloslaino25@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD pharmacology

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)