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NCT Number: NCT07337772

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

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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Key information

Conditions

Adrenal Cortex Hormones Anesthesia, Local Arthroplasty, Replacement, Knee

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location status: Recruiting

Location contact

Chaofan Zhang, PhD

CONTACT

[email protected]

+86059187982113

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Presence of neuromuscular dysfunction in the ipsilateral limb;
  • 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);
  • 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.

Treatment and study plan

LIA with different doses of Diprospan

Drug

LIA with different doses of Diprospan

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Score

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

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

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

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

    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.

  2. range of motion

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

    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.

  3. Total Postoperative Analgesic Consumption

    Time frame: Within the first 48 hours postoperatively

    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.

  4. . C-reactive Protein (CRP) Concentration

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

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

  5. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Erythrocyte sedimentation rate measured in millimeters per hour (mm/h). A nonspecific marker of inflammation.

  6. interleukin-6(IL-6)

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Serum IL-6 level measured in picograms per milliliter (pg/mL). A pro-inflammatory cytokine.

  7. Alanine Aminotransferase (ALT) Concentration

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Serum ALT level measured in units per liter (U/L). Elevated levels may indicate liver injury.

  8. Aspartate Aminotransferase (AST) Concentration

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Serum AST level measured in units per liter (U/L). Elevated levels may indicate liver or muscle injury.

  9. Serum Creatinine Concentration

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Serum creatinine level measured in micromoles per liter (μmol/L). Elevated levels may indicate impaired renal function.

  10. Blood Urea Nitrogen (BUN) Concentration

    Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.

    Blood urea nitrogen level measured in millimoles per liter (mmol/L). Elevated levels may be associated with dehydration or renal dysfunction.

  11. Incidence of Local Complications

    Time frame: 0-6 months postoperatively

    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.

  12. Incidence of Systemic Complications

    Time frame: 0-6 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chaofan Zhang, PhD

CONTACT

[email protected]

+86059187982113

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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