Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial

Conditions
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Localized Primary Osteoarthritis of Both Hips (Diagnosis), Osteoarthritis, Hip

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Normal Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline Solution<br>The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia . | Drug: Normal Saline Solution<br> <br> |
| Active Comparator: 10 mg Dexamethasone<br>The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia | Drug: Dexamethasone<br> <br> |
| Active Comparator: 40 mg Dexamethasone<br>The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia | Drug: Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scales for pain during five-metre walking (0-100) | 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; | at 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scales for pain during five-metre walking (0-100) | 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; | Postoperative at 48,72 hours. | 
| Visual analogue scales for pain on 45 degree active hip flexion (0-100) | 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; | Postoperative at 24,48,72 hours. | 
| Visual analogue scales for current pain at rest on supine position (0-100) | 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; | Postoperative at 6,24,48,72 hours. | 
| 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) | 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; | Postoperative at 0-24,24-48,48-72 hours. | 
| Visual analogue scales for nausea (0-100) | 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 | Postoperative at 6,24,48,72 hours | 
| Opioid consumption (mg.) | Opioid consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours | 
| Anti-emetic medicine consumption (mg.) | Anti-emetic medicine consumption (mg.) | Postoperative at 0-24,24-48,48-72 hours | 
| Wound complication | 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 | Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks. |