Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA (LIA;TKA)

Peking University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: 20mg triamcinolone; Drug: 40mg triamcinolone; Drug: without triamcinolone; Drug: 80mg triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05997238

Triamcinolone68480

Details and patient eligibility

About

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

Full description

Participants were enrolled according to protocol requirements. Patients who meet all inclusion criteria and do not have any exclusion criteria will be considered for inclusion in the study and will provide the relevant information used orally and in writing. Patients were divided into four groups according to the dose of triamcinolone in the peripheral infiltrating anesthetic preparation. All of which are appropriate for their surgical treatment, and the purpose of the study is to determine which formula is clinically better. All patients enrolled in this study were voluntary participants and signed informed consent. On the day of the surgery, the anesthesiologist prepares a mixture of medications based on patient groups, which are then handed to the operating room nurse. The timing, dose, and site of injection were consistent. Before the prosthesis is installed, the mixture is injected into the upper part of the patella, the posterior joint capsule, and the patellar tendon. After the prosthesis was installed, the mixture was injected into the lateral joint capsule and subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not know the type of mixed drug preparation injected by the patient.

Enrollment: 120 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

LIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Treatment:

Drug: without triamcinolone

Low dose triamcinolone

Experimental group

Description:

Add 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Treatment:

Drug: 20mg triamcinolone

Moderate dose triamcinolone

Experimental group

Description:

add 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Treatment:

Drug: 40mg triamcinolone

High dose triamcinolone

Experimental group

Description:

add 80mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Treatment:

Drug: 80mg triamcinolone