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Recruiting NCT07337772

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

No phase Interventional Adrenal Cortex Hormones Arthroplasty, Replacement, Knee Anesthesia, Local

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIA with different doses of Diprospan.
Who it may be relevant to
Registry conditions: Adrenal Cortex Hormones, Arthroplasty, Replacement, Knee, Anesthesia, Local. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Drug LIA with different doses of Diprospan
    LIA with different doses of Diprospan

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score [Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.]
  • range of motion [Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.]
  • Total Postoperative Analgesic Consumption [Time frame: Within the first 48 hours postoperatively]
  • . C-reactive Protein (CRP) Concentration [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Erythrocyte Sedimentation Rate (ESR) [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • interleukin-6(IL-6) [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Alanine Aminotransferase (ALT) Concentration [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Aspartate Aminotransferase (AST) Concentration [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Serum Creatinine Concentration [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Blood Urea Nitrogen (BUN) Concentration [Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.]
  • Incidence of Local Complications [Time frame: 0-6 months postoperatively]
  • Incidence of Systemic Complications [Time frame: 0-6 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT07337772 · QT2025013-ZX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗