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.
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 reduced kidney function (serum creatinine level above 2 mg/dl).
Sensitive to local anesthetics.
A history of hepatic insufficiency.
Chronic pain.
Parallel
Omega-3 fatty acids + Morphine group
DrugThe 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 group
Other interventionThe 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.
Total Morphine Requirement
Total morphine requirement in the 24 hours post-surgery.
Average Pain Score
Average Nausea Score
Average Pruritus Score
Average Vomiting Score
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