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

Primary Purpose

Analgesia

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

Analgesics

About this trial

This is an interventional treatment trial for Analgesia focused on measuring analgesia, non-opioid, patient-controlled analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Petrovsky Research National Centre of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

the first group: a fixed combination of Orphenadrine and Diclofenac

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

Arm Description

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

Outcomes

Primary Outcome Measures

visual-analog scale

dynamics of points 100 mm visual-analog scale

Secondary Outcome Measures

the minute inspiratory lung volume using a spirometer

Comparison of minute inspiratory lung volume befor/after research using a spirometer

opioid-sparing effect

Comparison of the number of opioid analgesics

adverse events

registration of adverse events

Full Information

NCT ID

NCT05322603

First Posted

March 26, 2022

Last Updated

August 18, 2023

Sponsor

Petrovsky National Research Centre of Surgery

1. Study Identification

Unique Protocol Identification Number

NCT05322603

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 18, 2022 (Actual)

Primary Completion Date

August 20, 2022 (Actual)

Study Completion Date

August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

Keywords

analgesia, non-opioid, patient-controlled analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

the first group: a fixed combination of Orphenadrine and Diclofenac

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)

Other Intervention Name(s)

Fixed combination of Orfenadrine and Diclofenac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Analgesics

Other Intervention Name(s)

Patient-controlled analgesia (with Morphine)

Intervention Description

A decrease in the pain severity (VAS)

Primary Outcome Measure Information:

Title

visual-analog scale

Description

dynamics of points 100 mm visual-analog scale

Time Frame

hospitalisation period, an average of 24 hours

Secondary Outcome Measure Information:

Title

the minute inspiratory lung volume using a spirometer

Description

Comparison of minute inspiratory lung volume befor/after research using a spirometer

Time Frame

hospitalisation period, an average of 24 hours

Title

opioid-sparing effect

Description

Comparison of the number of opioid analgesics

Time Frame

hospitalisation period, an average of 24 hours

Title

adverse events

Description

registration of adverse events

Time Frame

hospitalisation period, an average of 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander A. Eremenko, prof

Organizational Affiliation

Head of the Intensive Care Unit

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lyubov S. Sorokina

Organizational Affiliation

anesthesiologist-resuscitator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Petrovsky Research National Centre of Surgery

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Links:

URL

https://www.elibrary.ru/item.asp?id=49600253

Description

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

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

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