Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia

Study Overview
=================
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).

Official Title
-----------------
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)
* Drug: Analgesics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 18 years to 80 years inclusive surgical access - median sternotomy the first 2 hours after tracheal extubation clear consciousness and productive contact with the patient 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 no signs of renal dysfunction (KDIGO 0) stable state of hemodynamics Exclusion Criteria: a history of mental illness the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups renal and hepatic insufficiency perioperative brain lesions postoperative bleeding>1.4 ml/kg/hour severe cardiovascular (inotropic index>10) and/or respiratory (RaO2 /FiO2<200 mmHg) insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the first group: a fixed combination of Orphenadrine and Diclofenac<br>dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume | Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)<br>* A decrease in the pain severity (VAS);opioid-sparing effect<br>* Other names: Fixed combination of Orfenadrine and Diclofenac;|
| Experimental: the second group: patient-controlled analgesia (РСА) with Morphine<br>dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume | Drug: Analgesics<br>* A decrease in the pain severity (VAS)<br>* Other names: Patient-controlled analgesia (with Morphine);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual-analog scale | dynamics of points 100 mm visual-analog scale | hospitalisation period, an average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the minute inspiratory lung volume using a spirometer | Comparison of minute inspiratory lung volume befor/after research using a spirometer | hospitalisation period, an average of 24 hours | 
| opioid-sparing effect | Comparison of the number of opioid analgesics | hospitalisation period, an average of 24 hours | 
| adverse events | registration of adverse events | hospitalisation period, an average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, non-opioid, patient-controlled analgesia