Pain PostoperativePhase 2O3MORPHNCT07657468
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
A Phase 2 study testing Omega-3 fatty acids + Morphine group in people with Pain Postoperative and Analgesia, run by National University of La Rioja at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Postoperative, Analgesia
- What is being tested?
- Omega-3 fatty acids + Morphine group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Jun 2026to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Daily intake of analgesics or corticosteroids.
- Patients with Inflammatory bowel disease.
- Chronic opioid use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site
National University of La Rioja
La Rioja, La Rioja Province, F5300ALR
Carlos Laino, 0380154391553, carloslaino25@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pain Postoperative, Analgesia
- Being tested
- Omega-3 fatty acids + Morphine group, Placebo+ Morphine group
- Keywords
- analgesia, post-operation pain, analgesic adjunct, morphine reduction, omega-3 fatty acids, lapararoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acids + Morphine groupDrug
Also called Active treatment for post-operative pain
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.
Placebo+ Morphine groupOther
Also called Post-operative placebo for pain
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo+ Morphine group | Placebo comparator | Other: Placebo+ Morphine group Receives: Other: Placebo+ Morphine group |
| Omega-3 fatty acids + Morphine group. | Experimental | Omega-3 fatty acids + Morphine Receives: Drug: Omega-3 fatty acids + Morphine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Requirement
Total morphine requirement in the 24 hours post-surgery.
Measured: 24hs
Secondary outcomes (6)
Average Pain Score
Measured: 24 hs
Average Nausea Score
Measured: 24 hs
Average Pruritus Score
Measured: 24 hs
Average Vomiting Score
Measured: 24 hs
Average Respiratory Depression Score
Measured: 24hs
Average Urinary Retention Score
Measured: 24 hs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of La Rioja
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Horacio Laino, National University of La Rioja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657468
- Sponsor's protocol ID
- UNLAR
- Acronym
- O3MORPH
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40212170Arriaza 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.
PubMed 33905405Ikeda 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.
PubMed 8541338Escudero 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.
PubMed 26011306
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07657468
- Acronym / sponsor ID
- O3MORPH / UNLAR
- Conditions
- Pain Postoperative, Analgesia
- Keywords
- analgesia, post-operation pain, analgesic adjunct, morphine reduction, omega-3 fatty acids, lapararoscopic cholecystectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of La RiojaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo+ Morphine group | Placebo comparator | Other: Placebo+ Morphine groupOther: Placebo+ Morphine group |
| Omega-3 fatty acids + Morphine group. | Experimental | Drug: Omega-3 fatty acids + Morphine groupOmega-3 fatty acids + Morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acids + Morphine groupAlso: Active treatment for post-operative painThe 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. | Drug | Omega-3 fatty acids + Morphine group. |
| Placebo+ Morphine groupAlso: Post-operative placebo for painThe 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 | Placebo+ Morphine group |
Primary outcome
Total Morphine Requirement
Time frame: 24hs
Total morphine requirement in the 24 hours post-surgery.
6 secondary outcomes
Average Pain Score
Time frame: 24 hs
Average Nausea Score
Time frame: 24 hs
Average Pruritus Score
Time frame: 24 hs
Average Vomiting Score
Time frame: 24 hs
Average Respiratory Depression Score
Time frame: 24hs
Average Urinary Retention Score
Time frame: 24 hs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 40212170Athanasiou 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.
- Results publication: PubMed 33905405Arriaza 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.
- Results publication: PubMed 8541338Ikeda 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.
- Results publication: PubMed 26011306Escudero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 fatty acids + Morphine group in people with Pain Postoperative and Analgesia, run by National University of La Rioja at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Laino, Ph pharmacology (+5493804391553, carloslaino25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Requirement (time frame: 24hs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657468, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.