Localized Primary Osteoarthritis of Both Hips (Diagnosis), Osteoarthritis, Hip
Conditions
Brief summary
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
Detailed description
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg 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
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 years * Undergoing Elective, Primary, unilateral Total Hip arthroplasty * American Society of Anesthesiology (ASA) physical class 1-3 * BMI \< 40 kg/m2
Exclusion criteria
* History of previous musculoskeletal injury on the same hip * History of prior surgery on the same unilateral hip * History of adverse effects from medication utilized in this study * Contraindication to spinal anesthesia * History of psychiatric disorders or cognitive impairment * Contraindication to Corticosteroid * Poorly controlled Diabetes mellitus * 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 cataract or glaucoma or ocular hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scales for pain during five-metre walking (0-100) | at 24 hours postoperatively | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scales for pain on 45 degree active hip flexion (0-100) | Postoperative at 24,48,72 hours. | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
| Visual analogue scales for current pain at rest on supine position (0-100) | Postoperative at 6,24,48,72 hours. | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
| Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100) | Postoperative at 0-24,24-48,48-72 hours. | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
| Visual analogue scales for pain during five-metre walking (0-100) | Postoperative at 48,72 hours. | Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain; |
| Opioid consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours | Opioid consumption (mg.) |
| Anti-emetic medicine consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours | Anti-emetic medicine consumption (mg.) |
| Wound complication | Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks. | Wound complications (including periprosthetic joint infection and inadequate wound healing). Periprosthetic joint infection will be diagnosed using the criteria outlined by the Musculoskeletal Infection Society. Inadequate wound healing is defined as delayed wound healing or wound dehiscence |
| Visual analogue scales for nausea (0-100) | Postoperative at 6,24,48,72 hours | This outcome will be assessed in a form of visual analogue scale of 0-100 mm, in which 0 indicates no nausea or vomiting and 100 indicates the worst nausea or vomiting |
Countries
Thailand
Contacts
Primary ContactVutinan Manassoontornvuti, MD
Backup ContactNitchanant Kitcharanant, MD
Outcome results
None listed