Pain relief after CABG: tafalgin versus morphine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing CABG are assigned to one of two groups and given a single subcutaneous dose of pain medicine if their VAS pain score exceeds 3 during the first 24 hours after surgery: 10 mg morphine in the control group or 0.4 mg tafalgin in the experimental group. Pain relief is measured by change in the visual analogue scale (VAS); hemodynamic parameters and arterial blood gases are also monitored. Adverse events and drug-related problems are recorded to compare safety profiles. Eligible patients meet age, BMI, ASA, and infection/medication criteria and are treated at the enrolling hospital in Vladivostok.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ASA score less then 3, Signed inform consent, Absence of preoperative drugs administration that affects patient's perception of pain, No active infection process, BMI index \>18,5 kg\\m2 and \< 35 kg/m2, CABG, Age 18-75 years

Exclusion Criteria (the presence of at least one is sufficient):

* Failure to meet the inclusion criteria.
* High severity according to ASA (class IV or higher), which is associated with a high probability of prolonged mechanical ventilation, hemodynamic instability, and inability to use drugs affecting cardiac output and/or total peripheral vascular resistance.
* Contraindications to the use of tafalgin and/or morphine in accordance with the approved Summary of Product Characteristics (hypersensitivity to tafalgin, morphine, other opioids, or any excipients).
* Pregnancy or lactation.
* Acute or prolonged chronic intoxication with drugs or substances depressing the central nervous system (alcohol, barbiturates, opioid drugs, benzodiazepines).
* Use of monoamine oxidase inhibitors (MAOIs) or less than 14 days since their discontinuation.
* Liver cirrhosis, Child-Pugh class C.
* Acute renal failure requiring renal replacement therapy.
* Unresected malignant neoplasm.
* Mesenteric thrombosis or another severe abdominal pain syndrome of unclear etiology at the time of inclusion.
* Simultaneous participation in another clinical study.
* Marked CNS depression due to any cause, except for acute poisoning.
* COPD stage III and/or bronchial asthma in the exacerbation phase.
* Any clinically significant condition, disease, or circumstance in the medical history that, in the opinion of the investigator, precludes participation in the study.
* Psychiatric, physical, or other conditions preventing adequate assessment of the patient's behavior or proper compliance with the study protocol.
* Postoperative hemodynamic instability requiring high-dose inotropic and/or vasopressor support (epinephrine \> 0.1 μg/kg/min, dopamine \> 10 μg/kg/min, norepinephrine \> 0.2 μg/kg/min) and/or mechanical circulatory support.
* Refusal to participate in the study.

Where it's running

• Primorsky Regional General Hospital #1
  Vladivostok, Outside US, Russia Recruiting

Study contacts

• Principal investigator: Evgenii Kokarev, PhD
• Study coordinator: Vladislav Rublev, PhD
• Email: dr.rublev.v@gmail.com
• Phone: +79644530700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.