Pain relief after CABG: tafalgin versus morphine

Comparative Characteristics of Analgesia Methods in the Early Postoperative Period After Coronary Artery Bypass Grafting (CABG)

This will test whether tafalgin relieves pain after coronary artery bypass surgery as well as morphine in adult patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Primorsky Regional General Hospital #1 (other gov)
• Locations: 1 site (Vladivostok, Outside US)
• Trial ID: NCT07451522 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 years old undergoing CABG with ASA class I–II, BMI 18.5–35 kg/m2, no active infection or preoperative drugs that alter pain perception, and able to give informed consent are the ideal candidates.

Not a fit: Patients with ASA class IV or higher, pregnancy or lactation, hypersensitivity to tafalgin or opioids, active substance abuse, or other contraindications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If tafalgin is as effective as morphine, it could provide an alternative postoperative pain option with a different side-effect profile.

How similar studies have performed: Morphine is a well-established postoperative analgesic, while tafalgin is less well studied and has limited published head-to-head data against morphine.

Eligibility criteria

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 this trial is running

Vladivostok, Outside US

• Primorsky Regional General Hospital #1 — Vladivostok, Outside US, Russia (RECRUITING)

Study contacts

• Principal investigator: Evgenii Kokarev, PhD
• Study coordinator: Vladislav Rublev, PhD

Conditions: CAD - Coronary Artery Disease, CABG, Analgesia Assessment, CAD, Morphine, Tafalgin, VAS