Clinical trial NCT03542617: Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty
Official title: Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Localized Primary Osteoarthritis of Both Hips (Diagnosis)
Osteoarthritis, Hip
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scales for pain during five-metre walking (0-100)
timeFrame: at 24 hours postoperatively
Secondary outcomes:
measure: Visual analogue scales for pain during five-metre walking (0-100)
timeFrame: Postoperative at 48,72 hours.
measure: Visual analogue scales for pain on 45 degree active hip flexion (0-100)
timeFrame: Postoperative at 24,48,72 hours.
measure: Visual analogue scales for current pain at rest on supine position (0-100)
timeFrame: Postoperative at 6,24,48,72 hours.
measure: 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)
timeFrame: Postoperative at 0-24,24-48,48-72 hours.
measure: Visual analogue scales for nausea (0-100)
timeFrame: Postoperative at 6,24,48,72 hours
measure: Opioid consumption (mg.)
timeFrame: Postoperative at 0-24,24-48,48-72 hours
measure: Anti-emetic medicine consumption (mg.)
timeFrame: Postoperative at 0-24,24-48,48-72 hours
measure: Wound complication
timeFrame: Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.
Other outcomes:
Locations:
city: ChiangMai
country: Thailand
facility: Department of Orthopedics, Chiang Mai University
Study officials:
References: