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

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

This will test whether adding different doses of Diprospan to the local pain injection given during primary unilateral total knee replacement reduces postoperative pain and improves early recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07337772 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with unilateral knee osteoarthritis scheduled for primary unilateral total knee arthroplasty at the study hospital, with ASA physical status 1–3 and ability to give informed consent.

Not a fit: Patients with prior surgery or infection in the operative knee, non-osteoarthritis diagnoses, severe deformity, allergy to study drugs, ipsilateral neuromuscular dysfunction, or high opioid dependence are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could identify an optimal Diprospan dose for LIA that reduces pain, lowers opioid use, and speeds recovery after knee replacement.

How similar studies have performed: Previous randomized trials have shown that adding low-to-moderate doses of corticosteroids to local infiltration analgesia can reduce post-TKA pain, but the safety and efficacy of higher-dose Diprospan regimens remain less well studied.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian

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

Study contacts

• Study coordinator: Chaofan Zhang, PhD

Conditions Adrenal Cortex Hormones; Arthroplasty, Replacement, Knee; Anesthesia, Local