Petrovsky Research National Centre of Surgery
Moscow, Russia
NCT Number: NCT05322603
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Moscow, Russia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A decrease in the pain severity (VAS);opioid-sparing effect
Other names: Fixed combination of Orfenadrine and Diclofenac
A decrease in the pain severity (VAS)
Other names: Patient-controlled analgesia (with Morphine)
Time frame: hospitalisation period, an average of 24 hours
dynamics of points 100 mm visual-analog scale
Time frame: hospitalisation period, an average of 24 hours
Comparison of minute inspiratory lung volume befor/after research using a spirometer
Time frame: hospitalisation period, an average of 24 hours
Comparison of the number of opioid analgesics
Time frame: hospitalisation period, an average of 1 week
registration of adverse events
Petrovsky National Research Centre of Surgery
Other
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
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