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

NCT ID: NCT07337772

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-11-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High-dose group

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

Group Type: EXPERIMENTAL

LIA with different doses of Diprospan

Intervention Type: DRUG

LIA with different doses of Diprospan

Medium-dose group

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

Group Type: EXPERIMENTAL

LIA with different doses of Diprospan

Intervention Type: DRUG

LIA with different doses of Diprospan

Low-dose group

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

Group Type: EXPERIMENTAL

LIA with different doses of Diprospan

Intervention Type: DRUG

LIA with different doses of Diprospan

Control group

LIA without the addition of Diprospan

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LIA with different doses of Diprospan

LIA with different doses of Diprospan

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chaofan Zhang, PhD

Role: CONTACT

drcfzhang@fjmu.edu.cn

+86059187982113

Facility Contacts

Chaofan Zhang, PhD

Role: primary

drcfzhang@fjmu.edu.cn

+86059187982113

Other Identifiers

QT2025013-ZX

Identifier Type: -

Identifier Source: org_study_id