Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty
- Conditions
- Localized Primary Osteoarthritis of Both Hips (Diagnosis)Osteoarthritis, Hip
- Interventions
- Drug: Normal Saline Solution
- Registration Number
- NCT03542617
- Lead Sponsor
- Chiang Mai University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 57
- Age > 18 years
- Undergoing Elective, Primary, unilateral Total Hip arthroplasty
- American Society of Anesthesiology (ASA) physical class 1-3
- BMI < 40 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline Solution Normal Saline Solution The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia . 10 mg Dexamethasone Dexamethasone The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia 40 mg Dexamethasone Dexamethasone The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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;
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 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 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
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
Trial Locations
- Locations (1)
Department of Orthopedics, Chiang Mai University
🇹ðŸ‡ChiangMai, Thailand