Phase II, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy an… (NCT07657468) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
Argentina40 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether omega-3 fatty acids added to morphine can reduce the total amount of morphine needed after surgery — could reducing morphine use actually make a meaningful difference in my recovery, and is that a realistic goal for my specific situation?
2Since this is a Phase II trial, the safety and effectiveness of this omega-3 and morphine combination haven't been fully established yet — what are the known or potential risks of adding omega-3 supplementation on top of morphine for post-surgical pain, and how does that compare to just using standard morphine dosing?
3This trial is not yet recruiting, so it may be some time before it opens — given my upcoming surgery or current pain management needs, is waiting for this trial even a practical option, or would standard post-operative pain treatment be a better path for me right now?
4Since this is a double-blind, placebo-controlled trial, there's a chance I'd receive a placebo instead of the omega-3 supplement — how would my post-operative pain still be managed if I happened to be in the placebo group, and would I still receive morphine as needed?
5Are there any conditions I have, or medications I'm currently taking, that might affect whether I'd even be eligible to participate in a trial combining omega-3 fatty acids with morphine, and is this the kind of study you'd recommend I look into further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.