None listed
Conditions
Brief summary
This study is a prospective, three-arm, randomized controlled trial investigating the clinical outcomes of standard, intermediate, and high doses of intravenous dexamethasone administered during total knee replacement surgery for knee osteoarthritis. We hypothesise that higher doses of dexamethasone will reduce pain, lower opioid use, and improve early functional recovery compared with the standard dose.
Interventions
All patients will undergo total knee arthroplasty for end-stage osteoarthritis. Participants will be randomised in a 1:1:1 ratio to one of three intervention groups. Patients in the low-dose group will receive a single intravenous dose of 8 mg dexamethasone administered at induction of anaesthesia, prior to surgical incision. Patients in the intermediate-dose group will receive a single intravenous dose of 0.3 mg/kg dexamethasone administered at induction of anaesthesia. Patients in the high-dos
All patients will undergo total knee arthroplasty for end-stage osteoarthritis. Participants will be randomised in a 1:1:1 ratio to one of three intervention groups. Patients in the low-dose group will receive a single intravenous dose of 8 mg dexamethasone administered at induction of anaesthesia, prior to surgical incision. Patients in the intermediate-dose group will receive a single intravenous dose of 0.3 mg/kg dexamethasone administered at induction of anaesthesia. Patients in the high-dose group will receive a single intravenous dose of 1.0 mg/kg dexamethasone (capped at 100 mg) administered at induction of anaesthesia. The study drug will be prepared by the hospital pharmacist according to the randomisation schedule and dispensed in an identical, blinded syringe. The anaesthetist will administer the dose in theatre, and both preparation and administration will be documented in operation notes and medical records.
Sponsors
Perth Orthopaedic and Sports Medicine Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are male or non-pregnant females requiring a primary unilateral total knee replacement for osteoarthritis 2. American Society of Anaesthesiologists (ASA) physical status I-III.
Exclusion criteria
1. Known allergy to dexamethasone or other corticosteroids. 2. Active infection or systemic inflammatory disease requiring chronic corticosteroid use. 3. Recent peptic ulcer disease or gastrointestinal bleeding within the last 6 months. 4. Uncontrolled diabetes (HbA1c > 9% or fasting blood glucose > 200 mg/dL (11 mmol/L) on admission). 5. Severe psychiatric disorders. 6. Pregnancy or lactation. 7. Patients on chronic opioid therapy, who consume greater than 100mg daily morphine equivalent.
Outcome results
None listed