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

• Status: Recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Petrovsky National Research Centre of Surgery
• Treatments: Analgesics; Analgesics, Non-Narcotic; Diclofenac; Morphine

Criteria

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