Actively Recruiting
Comparative Characteristics of Analgesia Methods in the Early Postoperative Period After Coronary Artery Bypass Grafting (CABG)
Led by Primorsky Regional General Hospital #1 · Updated on 2026-03-05
100
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating postoperative pain relief methods in patients undergoing coronary artery bypass grafting (CABG). This clinical trial compares the effects of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) with morphine to see if tafalgin reduces pain scores similarly to morphine. The study also monitors the medical problems participants may experience while using tafalgin. This trial is interventional and randomized with a single-blind design. Participants are assigned to one of two groups: one group receives a single subcutaneous dose of morphine 10 mg based on a pain score greater than 3 within 24 hours after CABG. The other group receives a single subcutaneous dose of tafalgin 0.4 mg under the same pain score condition and timeframe. The trial focuses on early postoperative pain control in the first 24 hours after surgery. During the study, researchers assess pain using the Visual Analogue Scale (VAS) 24 hours after CABG. They also evaluate arterial blood gases, including pH, oxygen levels (PaO2), and carbon dioxide levels (PaCO2), as well as hemodynamic parameters like intra-arterial blood pressure and heart rate. Participants are monitored closely for safety and efficacy during this period. The study is scheduled to start in December 2025 and continue until March 2026.
CONDITIONS
Brief Title
Comparative Analysis of Analgesic Approaches in the Early Period After CABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA score less than 3
- Signed informed consent
- No preoperative drugs affecting pain perception
- No active infection
- Body mass index between 18.5 and 35 kg/m2
- Undergoing coronary artery bypass grafting (CABG)
- Age between 18 and 75 years
You will not qualify if you...
- Failure to meet inclusion criteria
- ASA class IV or higher
- Allergies or contraindications to tafalgin or morphine
- Pregnancy or breastfeeding
- Acute or chronic intoxication with central nervous system depressants
- Use of monoamine oxidase inhibitors or recent discontinuation less than 14 days
- Liver cirrhosis, Child-Pugh class C
- Acute renal failure requiring dialysis
- Unresected malignant tumor
- Severe abdominal pain of unclear cause
- Participation in another clinical trial
- Significant central nervous system depression except acute poisoning
- COPD stage III or bronchial asthma exacerbation
- Any condition preventing proper study compliance or assessment
- Postoperative hemodynamic instability requiring high-dose support
- Refusal to participate in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours after CABG
Participants receive postoperative analgesia after CABG with either tafalgin or morphine.
1 inpatient treatment period immediately following surgery
Trial Site Locations
Total: 1 location
1
Primorsky Regional General Hospital #1
Vladivostok, Outside US, Russia, 690091
Actively Recruiting
Research Team
V
Vladislav Rublev, PhD
E
Evgenii Kokarev, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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