Different doses of corticosteroid in local knee injection for total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers at the First Affiliated Hospital of Fujian Medical University are conducting a prospective, single-center, randomized controlled trial comparing different doses of the glucocorticoid Diprospan when added to local infiltration analgesia (LIA) during primary unilateral total knee arthroplasty for osteoarthritis. Eligible adults (ASA 1–3) will be randomly assigned to receive LIA with varying Diprospan doses at the time of surgery, and outcomes will include postoperative pain, opioid consumption, functional recovery, and adverse events. The trial will also specifically examine the safety and feasibility of a higher-dose glucocorticoid regimen. Results aim to identify an optimized LIA dosing strategy to improve postoperative recovery and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Chaofan Zhang, PhD
• Email: drcfzhang@fjmu.edu.cn
• Phone: +86059187982113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.