Analgesia
Conditions
Keywords
analgesia, non-opioid, patient-controlled analgesia
Brief summary
The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.
Detailed description
The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS \> 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).
Interventions
DRUGAnalgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)
A decrease in the pain severity (VAS);opioid-sparing effect
DRUGAnalgesics
A decrease in the pain severity (VAS)
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. age from 18 years to 80 years inclusive 2. surgical access - median sternotomy 3. the first 2 hours after tracheal extubation 4. clear consciousness and productive contact with the patient 5. absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding 6. no signs of renal dysfunction (KDIGO 0) 7. stable state of hemodynamics
Exclusion criteria
1. a history of mental illness 2. the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups 3. renal and hepatic insufficiency 4. perioperative brain lesions 5. postoperative bleeding\>1.4 ml/kg/hour 6. severe cardiovascular (inotropic index\>10) and/or respiratory (RaO2 /FiO2\<200 mmHg) insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual-analog scale | hospitalisation period, an average of 24 hours | dynamics of points 100 mm visual-analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the minute inspiratory lung volume using a spirometer | hospitalisation period, an average of 24 hours | Comparison of minute inspiratory lung volume befor/after research using a spirometer |
| opioid-sparing effect | hospitalisation period, an average of 24 hours | Comparison of the number of opioid analgesics |
| adverse events | hospitalisation period, an average of 1 week | registration of adverse events |
Countries
Russia
Outcome results
None listed