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)

June 13, 2026 updated by: Carlos Horacio Laino, National University of La Rioja

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • La Rioja Province
      • La Rioja, La Rioja Province, Argentina, F5300ALR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to provide written informed consent prior to any study procedures;
  2. Able to communicate clearly with the Investigator and staff;
  3. Males and females aged 18 to 65;
  4. American Society of Anesthesiologists (ASA) risk class of I to II;
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo+ Morphine group
Other: Placebo+ Morphine group
Other: 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.
Other Names:
  • Post-operative placebo for pain
Experimental: Omega-3 fatty acids + Morphine group.
Omega-3 fatty acids + Morphine
Drug: 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.
Other Names:
  • Active treatment for post-operative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Morphine Requirement
Time Frame: 24hs
Total morphine requirement in the 24 hours post-surgery.
24hs

Secondary Outcome Measures

Outcome Measure
Time Frame
Average Pain Score
Time Frame: 24 hs
24 hs
Average Nausea Score
Time Frame: 24 hs
24 hs
Average Pruritus Score
Time Frame: 24 hs
24 hs
Average Vomiting Score
Time Frame: 24 hs
24 hs
Average Respiratory Depression Score
Time Frame: 24hs
24hs
Average Urinary Retention Score
Time Frame: 24 hs
24 hs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of La Rioja

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 13, 2026

First Submitted That Met QC Criteria

June 13, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNLAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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