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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: without triamcinolone; Drug: 20mg triamcinolone; Drug: 80mg triamcinolone; Drug: 40mg triamcinolone

• Registration Number: NCT05997238
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-25
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-18
• Primary Completion: 2024-02-12
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	without triamcinolone	LIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.
Low dose triamcinolone	20mg triamcinolone	Add 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.
High dose triamcinolone	80mg triamcinolone	add 80mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.
Moderate dose triamcinolone	40mg triamcinolone	add 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Primary Outcome Measures

Name	Time	Method
pain visual analogue scale score	12 weeks after surgery	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

Secondary Outcome Measures

Name	Time	Method
Blood routine	Postoperative day 3	Assay index including white blood cell count and neutrophil count.
Complication rate	Three months after surgery	Follow-up visit
Test index of drainage liquefaction	Postoperative day 1	Assay index
Knee range of motion	Postoperative day 3	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index	Three months after surgery	The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China