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

P

Petrovsky National Research Centre of Surgery

Status

Completed

Conditions

Analgesia

Treatments

Drug: Analgesics
Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

Study type

Interventional

Funder types

Other

Identifiers

NCT05322603
00191200

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

the first group: a fixed combination of Orphenadrine and Diclofenac
Experimental group
Description:
dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume
Treatment:
Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)
the second group: patient-controlled analgesia (РСА) with Morphine
Experimental group
Description:
dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume
Treatment:
Drug: Analgesics

Trial contacts and locations

1

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Central trial contact

Alexander A. Eremenko, prof; Lyubov S. Sorokina

Data sourced from clinicaltrials.gov

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