Clinical trial NCT05997238: Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA
Official title: Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: total knee arthroplasty
triamcinolone
local infiltration anesthesia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain visual analogue scale score
timeFrame: 2 hours after surgery
measure: pain visual analogue scale score
timeFrame: 4 hours after surgery
measure: pain visual analogue scale score
timeFrame: 8 hours after surgery
measure: pain visual analogue scale score
timeFrame: 24 hours after surgery
measure: pain visual analogue scale score
timeFrame: 48 hours after surgery
measure: pain visual analogue scale score
timeFrame: 72 hours after surgery
measure: pain visual analogue scale score
timeFrame: 2 weeks after surgery
measure: pain visual analogue scale score
timeFrame: 4 weeks after surgery
measure: pain visual analogue scale score
timeFrame: 8 weeks after surgery
measure: pain visual analogue scale score
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Blood routine
timeFrame: Postoperative day 1
measure: Blood routine
timeFrame: Postoperative day 2
measure: Blood routine
timeFrame: Postoperative day 3
measure: Test index of drainage liquefaction
timeFrame: Postoperative day 1
measure: Complication rate
timeFrame: Three months after surgery
measure: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
timeFrame: Three months after surgery
measure: Knee range of motion
timeFrame: Postoperative day 1
measure: Knee range of motion
timeFrame: Postoperative day 2
measure: Knee range of motion
timeFrame: Postoperative day 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Director
name: Tian Hua, doctor
role: STUDY_CHAIR
References: