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

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

Detailed Description
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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 two 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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: 80mg triamcinolone
* Drug: 40mg triamcinolone


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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low-dose triamcinolone group<br>add 40mg triamcinolone to the LIA preparation | Drug: 40mg triamcinolone<br>* 40mg triamcinolone was added to the preparation<br>|
| high-dose triamcinolone group<br>add 80mg triamcinolone to the LIA preparation | Drug: 80mg triamcinolone<br>* 80mg triamcinolone was added to the preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee range of motion | The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery | Postoperative day 1 | 
| Knee range of motion | The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery | Postoperative day 2 | 
| Knee range of motion | The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery | Postoperative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood routine | Assay index | Postoperative day 1 | 
| Blood routine | Assay index | Postoperative day 2 | 
| Blood routine | Assay index | Postoperative day 3 | 
| Test index of drainage liquefaction | Assay index | Postoperative day 1 | 
| Complication rate | Follow-up visit | Three months after surgery | 
| The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function | Three months after surgery | 
| Morphine intake in 48 hours after surgery | The patient's use of additional analgesic drugs was recorded through the doctor's order system and converted to morphine equivalent | 48 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 2 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 4 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 8 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 24 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 48 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 72 hours after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 2 weeks after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 4 weeks after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 8 weeks after surgery | 
| pain visual analogue scale score | pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect | 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, triamcinolone, local infiltration anesthesia