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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose group | Experimental | LIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
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| Medium-dose group | Experimental | LIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
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| Low-dose group | Experimental | LIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
|
| Control group | No Intervention | LIA without the addition of Diprospan |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIA with different doses of Diprospan | Drug | LIA with different doses of Diprospan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain. | Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperatively, and at 3 weeks and 6 weeks postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaofan Zhang, PhD | Contact | +86059187982113 | drcfzhang@fjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350004 | China |
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| 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. |
| 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. | 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. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Erythrocyte Sedimentation Rate (ESR) | Erythrocyte sedimentation rate measured in millimeters per hour (mm/h). A nonspecific marker of inflammation. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| interleukin-6(IL-6) | Serum IL-6 level measured in picograms per milliliter (pg/mL). A pro-inflammatory cytokine. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Alanine Aminotransferase (ALT) Concentration | Serum ALT level measured in units per liter (U/L). Elevated levels may indicate liver injury. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Aspartate Aminotransferase (AST) Concentration | Serum AST level measured in units per liter (U/L). Elevated levels may indicate liver or muscle injury. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Serum Creatinine Concentration | Serum creatinine level measured in micromoles per liter (μmol/L). Elevated levels may indicate impaired renal function. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Blood Urea Nitrogen (BUN) Concentration | Blood urea nitrogen level measured in millimoles per liter (mmol/L). Elevated levels may be associated with dehydration or renal dysfunction. | Postoperative Day 1, Day 4, Week 3, and Week 6. |
| Incidence of Local Complications | The incidence of postoperative local complications at the surgical site, including but not limited to: wound exudation, poor wound healing, and periprosthetic joint infection. Incidence is defined as the number of participants experiencing at least one local complication, divided by the total number of participants in each group, expressed as a percentage. | 0-6 months postoperatively |
| Incidence of Systemic Complications | The incidence of postoperative systemic complications, including but not limited to: nausea, vomiting, deep vein thrombosis (DVT), and acute liver failure. Incidence is defined as the number of participants experiencing at least one systemic complication, divided by the total number of participants in each group, expressed as a percentage. | 0-6 months postoperatively |