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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi); Drug: Analgesics

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lyubov S. Sorokina; Phone Number: 89032157229; Email: soroka300@gmail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Petrovsky Research National Centre of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the first group: a fixed combination of Orphenadrine and Diclofenac; dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume	Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi); A decrease in the pain severity (VAS);opioid-sparing effect; Other Names: Fixed combination of Orfenadrine and Diclofenac
Experimental: the second group: patient-controlled analgesia (РСА) with Morphine; dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume	Drug: Analgesics; A decrease in the pain severity (VAS); Other Names: Patient-controlled analgesia (with Morphine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual-analog scale	dynamics of points 100 mm visual-analog scale	hospitalisation period, an average of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
opioid-sparing effect	Comparison of the number of opioid analgesics	hospitalisation period, an average of 24 hours
adverse events	registration of adverse events	hospitalisation period, an average of 1 week

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Lyubov S. Sorokina, anesthesiologist-resuscitator; Study Director: Alexander A. Eremenko, prof, Head of the Intensive Care Unit

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): August 20, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: analgesia, non-opioid, patient-controlled analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Morphine; Diclofenac; Analgesics; Analgesics, Non-Narcotic
• Other Study ID Numbers: 00191200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No