Osteoarthritis of the Knee
Conditions
Brief summary
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
Detailed description
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.
Interventions
DRUGDexamethasone
DRUGNormal saline solution
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 40 years (45) * Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46) * Undergoing elective, primary and unilateral total knee arthroplasty * American Society of Anesthesiology (ASA) physical status class 1-3 * BMI \< 40 kg/m2
Exclusion criteria
* History of active rheumatic diseases * History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis * History of previous surgery on the same knee * History of adverse effects from medications to be used in this study * Contraindication to spinal anesthesia * History of psychiatric disorders or cognitive impairment * Contraindication to corticosteroid agents * Poorly controlled diabetes mellitus (HbA1C \> 7.5) * Poorly controlled hypertension * History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease * Hepatic insufficiency (Child-Pugh score \> 5) * Renal insufficiency (Creatinine clearance \< 30 mL/min) * History of cataracts or glaucoma or ocular hypertension * History of steroid or immunosuppressive drug use within 6 months of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified WOMAC scores for pain at 12 weeks postoperative | 12 weeks | using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scales for pain during 45 degree active knee flexion (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs | — |
| Visual analogue scales for current pain at rest in a supine position (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs | — |
| Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100) | postoperatively at 0-24, 24-48, 48-72 hrs | — |
| Visual analogue scale values for nausea (0-100) | postoperatively at 6, 24, 30, 48, 54, 72 hrs | — |
| Visual analogue scales for pain during a five-meter walk (0-100) | postoperatively at 24, 30, 48, 54, 72 hrs | — |
| Anti-emetic medicine consumption (mg.) | during the first 0-24, 24-48, and 48-72 hrs | — |
| Maximum degree of active knee flexion | postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks | — |
| Modified WOMAC scores for pain | postoperatively at weeks 2 and 6 | using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire |
| Wound complications | evaluated postoperatively at weeks 2, 6 and 12 | — |
| Opioid consumption (mg.) | during the first 0-24, 24-48, and 48-72 hrs | — |
Countries
Thailand
Contacts
Primary ContactNitchanant Kitcharanant, MD
Outcome results
None listed