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

Fujian Medical University (FJMU)

Status: Enrolling

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

Treatments: Drug: LIA with different doses of Diprospan

Study type: Interventional

Funder types: Other

Identifiers

NCT07337772

QT2025013-ZX

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

High-dose group

Experimental group

Description:

LIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)

Treatment:

Drug: LIA with different doses of Diprospan

Medium-dose group

Experimental group

Description:

LIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)

Treatment:

Drug: LIA with different doses of Diprospan

Low-dose group

Experimental group

Description:

LIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)

Treatment:

Drug: LIA with different doses of Diprospan

Control group

No Intervention group

Description:

LIA without the addition of Diprospan