About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 years or older;
Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital;
Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3;
Ability to provide informed consent and sign a written informed consent form.
Disqualifiers
Previous surgery on the operative knee or a history of infection in the operative knee;
Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis);
Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30°);
Allergy to the relevant study drugs;
Trial design
Parallel
Treatments tested in this trial
LIA with different doses of Diprospan
DrugLIA with different doses of Diprospan
Treatment groups
Trial 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.
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.
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.
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.
. C-reactive Protein (CRP) Concentration
Serum CRP level measured in milligrams per liter (mg/L). A key marker of systemic inflammation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.