AnalgesiaNCT05322603
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia
A study testing Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) and Analgesics in people with Analgesia, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) and Analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 18 Mar 2022to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Analgesia
- Being tested
- Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi), Analgesics
- Keywords
- analgesia, non-opioid, patient-controlled analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)Drug
Also called Fixed combination of Orfenadrine and Diclofenac
A decrease in the pain severity (VAS);opioid-sparing effect
AnalgesicsDrug
Also called Patient-controlled analgesia (with Morphine)
A decrease in the pain severity (VAS)
| Study group | Role | What they receive |
|---|---|---|
| the first group: a fixed combination of Orphenadrine and Diclofenac | Experimental | dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume Receives: 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 Receives: Drug: Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual-analog scale
dynamics of points 100 mm visual-analog scale
Measured: hospitalisation period, an average of 24 hours
Secondary outcomes (3)
the minute inspiratory lung volume using a spirometer
Comparison of minute inspiratory lung volume befor/after research using a spirometer
Measured: hospitalisation period, an average of 24 hours
opioid-sparing effect
Comparison of the number of opioid analgesics
Measured: hospitalisation period, an average of 24 hours
adverse events
registration of adverse events
Measured: hospitalisation period, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start18 Mar 2022
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Eremenko, Petrovsky National Research Centre of Surgery
- Investigators
- Alexander A. Eremenko, prof, Study director, Head of the Intensive Care UnitLyubov S. Sorokina, Principal investigator, anesthesiologist-resuscitator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322603
- Sponsor's protocol ID
- 00191200
- Status last verified
- Aug 2023
- First submitted
- 26 Mar 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05322603
- Acronym / sponsor ID
- 00191200
- Conditions
- Analgesia
- Keywords
- analgesia, non-opioid, patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the first group: a fixed combination of Orphenadrine and Diclofenac | Experimental | Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume |
| the second group: patient-controlled analgesia (РСА) with Morphine | Experimental | Drug: Analgesicsdynamics of points 100 mm visual-analog scale,minute inspiratory lung volume |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)Also: Fixed combination of Orfenadrine and DiclofenacA decrease in the pain severity (VAS);opioid-sparing effect | Drug | the first group: a fixed combination of Orphenadrine and Diclofenac |
| AnalgesicsAlso: Patient-controlled analgesia (with Morphine)A decrease in the pain severity (VAS) | Drug | the second group: patient-controlled analgesia (РСА) with Morphine |
Primary outcome
visual-analog scale
Time frame: hospitalisation period, an average of 24 hours
dynamics of points 100 mm visual-analog scale
3 secondary outcomes
the minute inspiratory lung volume using a spirometer
Time frame: hospitalisation period, an average of 24 hours
opioid-sparing effect
Time frame: hospitalisation period, an average of 24 hours
adverse events
Time frame: hospitalisation period, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander A. Eremenko, prof study director
Head of the Intensive Care Unit
Lyubov S. Sorokina principal investigator
anesthesiologist-resuscitator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) and Analgesics in people with Analgesia, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual-analog scale (time frame: hospitalisation period, an average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.