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A randomized controlled study protocol on the effect of small multiple intravenous doses combined with local application of glucocorticoids on early rehabilitation and knee function after total knee arthroplasty

A randomized controlled study protocol on the effect of small multiple intravenous doses combined with local application of glucocorticoids on early rehabilitation and knee function after total knee arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115017
Enrollment
Unknown
Registered
2025-12-21
Start date
2025-04-27
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

End-stage osteoarthropathy of the knee

Interventions

Group with two applications of intravenous dexamethasone:Intravenous dexamethasone at induction of anaesthesia (preoperative) and postoperatively
Group with one applications of intravenous dexamethasone:Induction of anaesthesia (preoperative) via intravenous dexamethasone
Intravenous combined topical dexamethasone group:Intravenous co-topical dexamethasone
Topical dexamethasone group:Intraoperative local infiltration of the joint cavity with dexamethasone injection
blank control group:No other additional treatment

Sponsors

the Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with end-stage arthritis of the knee and scheduled to undergo an initial unilateral TKA; 2.Age greater than 50 years;

Exclusion criteria

Exclusion criteria: 1.Patients with prior hypersensitivity to dexamethasone or a history of contraindication to dexamethasone; 2.Patients using opioids or dexamethasone within three months prior to surgery; 3.Patients with active peptic ulcer disease, psychological or neurological disorders affecting pain perception; 4.Patients with rheumatoid disease, systemic lupus erythematosus, or ankylosing spondylitis who have been on hormone therapy for the past six months; 5.Patients undergoing TKA for infectious reasons;

Design outcomes

Primary

MeasureTime frame
Number of occurrences of postoperative nausea and vomiting (PONV);Pain scores;

Secondary

MeasureTime frame
Use of rescue analgesics;Neutrophil ratio;Quality of Recovery Score (QoR15);CRP;postoperative complication;Knee Society Functionality Score;Range of motion;Post-operative length of stay;white blood cell count;IL-6;Degree of knee swelling;erythrocyte sedimentation rate;Use of Emergency Anti-Vomiting Medications;

Countries

China

Contacts

Public ContactXu Wei

the Second Affiliated Hospital of Soochow University

13962157016@139.com+86 512 6778 4116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026