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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFirst Affiliated Hospital of Fujian Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • LIA with different doses of Diprospan

    Drug

    LIA with different doses of Diprospan

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: High-dose groupExperimental treatment 1 intervention
Group B: Medium-dose groupExperimental treatment 1 intervention
Group C: Low-dose groupExperimental treatment 1 intervention
Group D: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS) Pain Score

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

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

Secondary outcomes

1

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.

Time frame
Preoperatively, and at 3 weeks and 6 weeks postoperatively.
2

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.

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

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.

Time frame
Within the first 48 hours postoperatively
4

. C-reactive Protein (CRP) Concentration

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

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

Other outcomes

Sponsors and contacts

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