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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-05

Study Completion Date

2020-12-31

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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline Solution

The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia .

Group Type PLACEBO_COMPARATOR

Normal Saline Solution

Intervention Type DRUG

10 mg Dexamethasone

The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

40 mg Dexamethasone

The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Interventions

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Dexamethasone

Intervention Type DRUG

Normal Saline Solution

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Nitchanant Kitcharanant

Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A prospective, double-blind, randomized controlled trial

Responsibility Role PRINCIPAL_INVESTIGATOR