Does adding corticosteroids to the cocktail solution for Local Infiltration Analgesia in TKA minimize knee inflammation? A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260104002

Enrollment

Registered

2026-01-04

Start date

2026-01-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Preoperative and post operative synovial cytokines 2. Post operative functional outcomes and complication (CF-LIA and C-LIA) 3. Postoperative Pain (CF-LIA and C-LIA) 4.Knee Osteoarthritis 5.Total Knee Arthroplasty total knee arthroplasty, proinflammatory cytokines, corticosteroid-based local infiltration analgesia, corticosteroid-free local infiltration analgesia

Interventions

The standard LIA cocktail will include 0.5% Bupivacaine 20 mL, Adrenaline (1:1000) 0.3 mL, Ketorolac 30 mg, and normal saline to make up a total volume of 40 ml. After satisfactory implant trialing, t

Placebo Comparator Drug,Experimental Drug

corticosteroid-free LIA (CF-LIA),corticosteroid-containing LIA (C-LIA)

Eligibility

Sex/Gender

All

Age

65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Primary varus knee OA 2. Undergoing either unilateral or bilateral TKA 3. Pre-operative ROM within 0-5 degrees of extension and more than 120 degrees of flexion 4. No prior surgical intervention on the knee designated for study

Exclusion criteria

Exclusion criteria: 1. History of intra-articular injection to the index knee - whether corticosteroid, hyaluronic acid (HA), or platelet-rich plasma (PRP) - within 3 months prior to surgery 2. History of taking any anti-inflammatory medications within 1 month prior to surgery 3. Having autoimmune diseases 4. History of infection involving the index knee joint 5. History of significant trauma to the knee designated for study 6. Consent denial

Design outcomes

Primary

Measure	Time frame
Proinflammatory and Anti-inflammatory Cytokines day 0 and day 3 Cytometric Bead Array	—

Secondary

Measure	Time frame
knee inflammatory parameters 6,12,24,48,72 hours and 2 weeks numeric pain rating scale, range of motion, knee circumference, knee surface temperature,patient-reported outcome measures (PROMs) Preoperative, day 3, 2 weeks WOMAC score, KOOS-12 ,performance-based outcomes Preoperative, day 3, 2 weeks 5TST, TUG, 3MWT,Complications 6,12,24,48,72 hours and 2 weeks clinical report, physical examination, medical records	—

Measure

Time frame

knee inflammatory parameters 6,12,24,48,72 hours and 2 weeks numeric pain rating scale, range of motion, knee circumference, knee surface temperature,patient-reported outcome measures (PROMs) Preoperative, day 3, 2 weeks WOMAC score, KOOS-12 ,performance-based outcomes Preoperative, day 3, 2 weeks 5TST, TUG, 3MWT,Complications 6,12,24,48,72 hours and 2 weeks clinical report, physical examination, medical records

—

Countries

Thailand

Contacts

Public ContactChavarin Amarase

Faculty of medicine, Chulalongkorn University

orthotrauma@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026