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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322603
• Other study ID #: 00191200
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: August 20, 2022

Study information

• Verified date: August 2023
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)
A decrease in the pain severity (VAS);opioid-sparing effect
• Analgesics
A decrease in the pain severity (VAS)

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Centre of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual-analog scale	dynamics of points 100 mm visual-analog scale	hospitalisation period, an average of 24 hours
Secondary	the minute inspiratory lung volume using a spirometer	Comparison of minute inspiratory lung volume befor/after research using a spirometer	hospitalisation period, an average of 24 hours
Secondary	opioid-sparing effect	Comparison of the number of opioid analgesics	hospitalisation period, an average of 24 hours
Secondary	adverse events	registration of adverse events	hospitalisation period, an average of 1 week

External Links

•   ANALGESIC AND OPIOID-SPARING EFFECTS OF A FIXED COMBINATION OF DICLOFENAC AND ORPHENADRINE IN THE EARLY POSTOPERATIVE PERIOD IN CARDIAC SURGERY PATIENTS