About this trial
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
Qualifiers
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;
Disqualifiers
Patients with reduced kidney function (serum creatinine level above 2 mg/dl).
Sensitive to local anesthetics.
A history of hepatic insufficiency.
Chronic pain.
Trial design
Treatments tested in this trial
- Omega-3 fatty acids + Morphine group
- Placebo+ Morphine group