Analgesia, Pain Postoperative
Conditions
Keywords
analgesia, post-operation pain, analgesic adjunct, morphine reduction, omega-3 fatty acids, lapararoscopic cholecystectomy
Brief 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.
Detailed description
Currently, the most widely used drugs for treating post-surgical pain are opioids, such as morphine. Morphine works primarily by activating specific opioid receptors, providing significant pain relief but also causing side effects that limit its use. Preclinical studies in our laboratory have shown that combined treatment with morphine and omega-3 fatty acids produces an additive enhancement of morphine's analgesic effect, mediated by the opioid pathway. Furthermore, we observed that this combined treatment prevents development of tolerance to morphine's analgesic effect and reduces some of the drug's adverse effects. In order to reduce morphine dose and decrease or avoid morphine's side effects, the present study was designed to administer omega-3 fatty acids as an adjunct to morphine for acute postoperative pain following laparoscopic cholecystectomy.
Interventions
DRUGOmega-3 fatty acids + Morphine group
The 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.
OTHERPlacebo+ Morphine group
The 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.
Sponsors
National University of La Rioja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Morphine Requirement | 24hs | Total morphine requirement in the 24 hours post-surgery. |
Secondary
| Measure | Time frame |
|---|---|
| Average Pain Score | 24 hs |
| Average Nausea Score | 24 hs |
| Average Pruritus Score | 24 hs |
| Average Vomiting Score | 24 hs |
| Average Respiratory Depression Score | 24hs |
| Average Urinary Retention Score | 24 hs |
Countries
Argentina
Contacts
CONTACTCarlos Laino, Ph pharmacology
Outcome results
None listed