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

NCT07337772 | Recruiting

• 1 other identifier: QT2025013-ZX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

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

Secondary Outcomes (12)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

  Preoperatively, and at 3 weeks and 6 weeks postoperatively.

• range of motion

  Preoperatively, and at 3 weeks and 6 weeks postoperatively.

• Total Postoperative Analgesic Consumption

  Within the first 48 hours postoperatively

• . C-reactive Protein (CRP) Concentration

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

• Erythrocyte Sedimentation Rate (ESR)

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

Study Arms (4)

High-dose group

EXPERIMENTAL

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

Drug: LIA with different doses of Diprospan

Medium-dose group

EXPERIMENTAL

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

Drug: LIA with different doses of Diprospan

Low-dose group

EXPERIMENTAL

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

Drug: LIA with different doses of Diprospan

Control group

NO INTERVENTION

LIA without the addition of Diprospan

Interventions

LIA with different doses of Diprospan DRUG

LIA with different doses of Diprospan

High-dose group; Low-dose group; Medium-dose group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Presence of neuromuscular dysfunction in the ipsilateral limb;
• 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);
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

Central Study Contacts

Chaofan Zhang, PhD

CONTACT

+86059187982113; drcfzhang@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)