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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07657468). StuddyBuddy aggregates publicly available trial information.