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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
Conditions: Pain Postoperative, Analgesia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 40
Sponsor: National University of La Rioja
Location: National University of La Rioja La Rioja La Rioja Province
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07657468). StuddyBuddy aggregates publicly available trial information.