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Completed

NCT Number: NCT05322603

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petrovsky Research National Centre of Surgery

Moscow, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

Drug

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

Other names: Fixed combination of Orfenadrine and Diclofenac

Analgesics

Drug

A decrease in the pain severity (VAS)

Other names: Patient-controlled analgesia (with Morphine)

Primary outcomes

  1. visual-analog scale

    Time frame: hospitalisation period, an average of 24 hours

    dynamics of points 100 mm visual-analog scale

Secondary outcomes

  1. the minute inspiratory lung volume using a spirometer

    Time frame: hospitalisation period, an average of 24 hours

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

  2. opioid-sparing effect

    Time frame: hospitalisation period, an average of 24 hours

    Comparison of the number of opioid analgesics

  3. adverse events

    Time frame: hospitalisation period, an average of 1 week

    registration of adverse events

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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