Clinical trial NCT05322603: Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia
Official title: Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: analgesia, non-opioid, patient-controlled analgesia
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: visual-analog scale
timeFrame: hospitalisation period, an average of 24 hours
Secondary outcomes:
measure: the minute inspiratory lung volume using a spirometer
timeFrame: hospitalisation period, an average of 24 hours
measure: opioid-sparing effect
timeFrame: hospitalisation period, an average of 24 hours
measure: adverse events
timeFrame: hospitalisation period, an average of 1 week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery
Study officials:
affiliation: Head of the Intensive Care Unit
name: Alexander A. Eremenko, prof
role: STUDY_DIRECTOR
affiliation: anesthesiologist-resuscitator
name: Lyubov S. Sorokina
role: PRINCIPAL_INVESTIGATOR
References: