Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

First Affiliated Hospital of Fujian Medical University120 enrolled

Overview

This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Through this research, the investigators hope to provide an optimized solution for post-TKA pain management, improve patients' postoperative recovery and quality of life, and offer scientific evidence for pain management following TKA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Adrenal Cortex Hormones Arthroplasty, Replacement, Knee Anesthesia, Local

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female participants aged 18 years or older; 2. Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital; 3. Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3; 4. Ability to provide informed consent and sign a written informed consent form. Exclusion Criteria: 1. Previous surgery on the operative knee or a history of infection in the operative knee; 2. Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis); 3. Severe osteoarthritis (including flexion contracture \>30° or varus/valgus deformity \>30°); 4. Allergy to the relevant study drugs; 5. Presence of neuromuscular dysfunction in the ipsilateral limb; 6. Dependence on anesthetic drugs (defined as weekly use of opioids exceeding 100 mg morphine equivalents or local anesthetics for preoperative pain control for more than 3 months); 7. Poor systemic condition, including but not limited to: glycated hemoglobin (HbA1c) level \>12%; blood pressure \>170/110 mmHg (1 mmHg = 0.133 kPa); history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure, or any acute coronary event within 6 months; dialysis or renal transplantation; pregnancy or lactation.

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) Pain Score

VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.

Time frame: Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.

Secondary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

Patient-reported outcome measuring pain, stiffness, and physical function in knee osteoarthritis. Total score ranges from 0 (best) to 96 (worst). Lower scores indicate better outcomes.

Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.

range of motion

The range of motion (flexion and extension) of the operated knee will be measured using a standard goniometer. The primary outcome is the maximum active flexion angle (in degrees). A greater range of motion indicates better functional recovery.

Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.

Total Postoperative Analgesic Consumption

The total consumption of all analgesic medications administered for postoperative pain control. All doses will be converted to morphine milligram equivalents (MME) for opioids (e.g.,tramadol) and to standardized dosages for non-opioid analgesics (e.g., ibuprofen, celecoxib, acetaminophen). The outcome will be reported as total MME (for opioids) and total standardized dosage (for non-opioids), both as continuous measures.

Time frame: Within the first 48 hours postoperatively

. C-reactive Protein (CRP) Concentration

Serum CRP level measured in milligrams per liter (mg/L). A key marker of systemic inflammation.