[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641067":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":88,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National University of La Rioja","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo+ Morphine group","PLACEBO_COMPARATOR","Other: Placebo+ Morphine group",[11],{"label":14,"type":15,"description":16,"interventionNames":17},"Omega-3 fatty acids + Morphine group.","EXPERIMENTAL","Omega-3 fatty acids + Morphine",[18],"Drug: Omega-3 fatty acids + Morphine group",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Omega-3 fatty acids + Morphine group","The omega-3 fatty acids will be given twice before surgery (1680 mg\u002Fday) once on the day of surgery (840 mg) with 0,04 mg\u002Fkg morphine, and twice the day after surgery (1680 mg\u002Fday). It will be administered with lunch or dinner.",[14],[26],"Active treatment for post-operative pain",{"type":6,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"The placebo will be given twice before surgery (1680 mg\u002Fday) once on the day of surgery (840 mg) with 0,04 mg\u002Fkg morphine, and twice the day after surgery (1680 mg\u002Fday). It will be administered with lunch or dinner.",[9],[31],"Post-operative placebo for pain",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Carlos Laino, Ph pharmacology","CONTACT","+5493804391553","carloslaino25@gmail.com",[40],{"facility":5,"status":32,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"La Rioja","La Rioja Province","F5300ALR","Argentina","AR",{"type":47,"coordinates":48},"Point",[49,50],-66.85637,-29.41328,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":32,"email":38},"Carlos Laino","0380154391553",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Carlos Horacio Laino","PhD pharmacology","100641067","phase-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-100641067",false,"NCT07657468","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","Inclusion Criteria:\n\n1. Able to provide written informed consent prior to any study procedures;\n2. Able to communicate clearly with the Investigator and staff;\n3. Males and females aged 18 to 65;\n4. American Society of Anesthesiologists (ASA) risk class of I to II;\n5. Patients with an indication for laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n* Patients with reduced kidney function (serum creatinine level above 2 mg\u002Fdl).\n* Sensitive to local anesthetics.\n* A history of hepatic insufficiency.\n* Chronic pain.\n* Patients with diabetes.\n* Patients with Body Mass Index (BMI) greater than 35 kg\u002Fm2.\n* Daily intake of analgesics or corticosteroids.\n* Patients with Inflammatory bowel disease.\n* Chronic opioid use.",true,"ALL","18 Years","65 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","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.\n\nPatients 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\u002Fkg 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.",[79,80],"Pain Postoperative","Analgesia",[82,83,84,85,86,87],"analgesia","post-operation pain","analgesic adjunct","morphine reduction","omega-3 fatty acids","lapararoscopic cholecystectomy","NOT_YET_RECRUITING","2026-06-13",{"date":91,"type":92},"2026-06-18","ACTUAL",{"date":94,"type":73},"2026-06-15",{"date":96,"type":73},"2026-10-31",{"name":5,"class":6},1]