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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2022-08-20

Brief Summary

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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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Detailed Description

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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).

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the first group: a fixed combination of Orphenadrine and Diclofenac

dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume

Group Type EXPERIMENTAL

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

Intervention Type DRUG

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

the second group: patient-controlled analgesia (РСА) with Morphine

dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume

Group Type EXPERIMENTAL

Analgesics

Intervention Type DRUG

A decrease in the pain severity (VAS)

Interventions

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Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

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

Intervention Type DRUG

Analgesics

A decrease in the pain severity (VAS)

Intervention Type DRUG

Other Intervention Names

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Fixed combination of Orfenadrine and Diclofenac Patient-controlled analgesia (with Morphine)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes