Comparative Analysis of Analgesic Approaches in the Early Period After CABG (CABG-PAIN)

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

The goal of this clinical trial is to study postoperative analgesia in patients undergoing CABG. And learn if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) treats pain not inferiory then morphine. The main questions it aims to answer are:

Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)?

Participants will:

Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score > 3 during 24 hours after CABG.

Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score > 3 during 24 hours after CABG.

Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.

Study Overview

• Status: Recruiting
• Conditions: CABG; CAD - Coronary Artery Disease; Analgesia Assessment
• Intervention / Treatment: Drug: Morphine (+); Drug: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vladislav Rublev, PhD; Phone Number: +79644530700; Email: dr.rublev.v@gmail.com
• Study Contact Backup: Name: Evgenii Kokarev, PhD; Phone Number: +79098591131; Email: kokareve@yandex.ru

Study Locations

• Russia
  • Outside US
    • Vladivostok, Outside US, Russia, 690091
      • Recruiting
      • Primorsky Regional General Hospital #1
      • Contact: Vladislav Rublev; Phone Number: 89644530700; Email: dr.rublev.v@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine; Patients after CABG with morphine postoperative analgesia	Drug: Morphine (+); Postoperative analgesia wtih morphine
Experimental: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide); Patients after CABG with tafalgin postoperative analgesia	Drug: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide); Postoperative analgesia after CABG with tafalgin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients	24 hours after CABG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Gases (ABGs) pH	Arterial blood gases are a diagnostic test measuring pH levels in arterial blood to evaluate lung function and acid-base balance.	24 hours after CABG
Arterial Blood Gases (ABGs) oxygen (PaO2) levels	Arterial blood gases are a diagnostic test measuring oxygen (PaO2) levels in arterial blood to evaluate lung function and acid-base balance.	24 hours after CABG
Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels	Arterial blood gases are a diagnostic test measuring carbon dioxide (PaCO2) levels in arterial blood to evaluate lung function and acid-base balance.	24 hours after CABG
Haemodynamics evaluation (Intra-arterial blood pressure (IABP))	Intra-arterial blood pressure (IABP) monitoring provides continuous, real-time arterial pressure measurement, serving as the gold standard for managing hypertension in critical care.	24 hours after CABG
Haemodynamics evaluation (Heart rate (HR))	This assessment evaluates cardiac function, identifies rhythm irregularities	24 hours after CABG

Collaborators and Investigators

• Sponsor: Primorsky Regional General Hospital #1
• Investigators: Principal Investigator: Evgenii Kokarev, PhD

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CABG; VAS; Morphine; CAD; Tafalgin
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine
• Other Study ID Numbers: LEC028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No