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

NCT05322603 | Completed

• 1 other identifier: 00191200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

analgesia, non-opioid, patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• visual-analog scale

  dynamics of points 100 mm visual-analog scale

  hospitalisation period, an average of 24 hours

Secondary Outcomes (3)

• the minute inspiratory lung volume using a spirometer

  hospitalisation period, an average of 24 hours

• opioid-sparing effect

  hospitalisation period, an average of 24 hours

• adverse events

  hospitalisation period, an average of 1 week

Study Arms (2)

the first group: a fixed combination of Orphenadrine and Diclofenac

EXPERIMENTAL

dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume

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

the second group: patient-controlled analgesia (РСА) with Morphine

EXPERIMENTAL

dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume

Drug: Analgesics

Interventions

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) DRUG

A decrease in the pain severity (VAS);opioid-sparing effect

Also known as: Fixed combination of Orfenadrine and Diclofenac

the first group: a fixed combination of Orphenadrine and Diclofenac

Analgesics DRUG

A decrease in the pain severity (VAS)

Also known as: Patient-controlled analgesia (with Morphine)

the second group: patient-controlled analgesia (РСА) with Morphine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 18 years to 80 years inclusive
• surgical access - median sternotomy
• the first 2 hours after tracheal extubation
• clear consciousness and productive contact with the patient
• 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
• no signs of renal dysfunction (KDIGO 0)
• stable state of hemodynamics

You may not qualify if:

• a history of mental illness
• the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
• renal and hepatic insufficiency
• perioperative brain lesions
• postoperative bleeding\>1.4 ml/kg/hour
• severe cardiovascular (inotropic index\>10) and/or respiratory (RaO2 /FiO2\<200 mmHg) insufficiency

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky Research National Centre of Surgery

Moscow, Russia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Non-Narcotic; Diclofenac; Analgesics; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesia; Anesthesia and Analgesia

Study Officials

• Alexander A. Eremenko, prof

  Head of the Intensive Care Unit

  STUDY DIRECTOR

• Lyubov S. Sorokina

  anesthesiologist-resuscitator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 12, 2022
• Study Start: March 18, 2022
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

RU (1)