Pain, Acute
Conditions
Keywords
oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty
Brief summary
To compare efficacy of oral steroid in controlling pain after TKA
Detailed description
To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy
Interventions
DRUGDexamethasone Oral
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis of the knee who undergoing unilateral TKA * ASA class I-III * Informed consent * Good cognitive function
Exclusion criteria
* Uncontrolled DM (HbA1C \> 7) * Uncontrolled HT * Morbid obesity (BMI \> 40) * History of bleeding in GI tract * Corticosteroid used within 6 months * Sever liver or renal impairments * Studied drug allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 12, 24 ,36, 48, 60 and 72 hours after surgery | VAS for pain (0-100) at rest and on motion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion of the knee | 24, 72 hours then 2, 6, 12 weeks after surgery | Flexion and extension angle |
| Functional outcome | 2, 6,12 weeks after surgery | Modified WOMAC score |
| nausea and vomiting | in the first 72 hours after surgery | rate of nausea and vomiting |
| inflammatory level | At 8.00 am of 1, 2, 3 days and 2 weeks after surgery | C-reactive protein level |
| Wound complications | 3 months after surgery | Deep and superficial wound infection, wound dehiscense |
| Blood sugar | At 8.00 am of 1, 2, 3 days after surgery | Fasting blood sugar level |
Countries
Thailand
Outcome results
None listed