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

Petrovsky National Research Centre of Surgery60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Analgesia

Interventions

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)DRUG

A decrease in the pain severity (VAS);opioid-sparing effect

AnalgesicsDRUG

A decrease in the pain severity (VAS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Petrovsky Research National Centre of Surgery

Moscow, Russia

Outcomes

Primary Outcomes

visual-analog scale

dynamics of points 100 mm visual-analog scale

Time frame: hospitalisation period, an average of 24 hours

Secondary Outcomes

the minute inspiratory lung volume using a spirometer

Comparison of minute inspiratory lung volume befor/after research using a spirometer

Time frame: hospitalisation period, an average of 24 hours

opioid-sparing effect

Comparison of the number of opioid analgesics

Time frame: hospitalisation period, an average of 24 hours

adverse events

registration of adverse events

Time frame: hospitalisation period, an average of 1 week

Data from ClinicalTrials.gov

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