Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty

Triamcinolone68480

To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

2023-04-25

2024-02-12

2024-05-01

Active (not recruiting)

Early phase I

120

Inclusion Criteria: 1. age in the range of 50 to 85 years old 2. patients with knee osteoarthritis requiring primary unilateral total knee replacement 3. the body mass index in the range of 18 to 36 kg/m2 4. possess the physical status I-III of American Society of Anesthesiologists 5. the patient and his family members agree and sign the informed consent Exclusion Criteria: 1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.) 2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc 3. Flexion deformity ≥30°, internal and external varus deformity ≥15° 4. People allergic to the drugs used in this study 5. Patients who had used glucocorticoids within 3 months before surgery

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using a 1:1:1:1 assignment and random blocks of 12, 8 or 4 to ensure the concealability of the assignment. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using 1:1 assignments and random blocks of 8, 6 or 4 to ensure the invisibility of assignments. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled. On the day of surgery, the anesthesiologist prepares to mix the drug preparation after opening the sealed envelope, which is then handed to the operating room nurse. The patient, the rehabilitation physician, and the ward nurse did not know the type of drug mixture the patient was injected with.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

2024-03-26