Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

Phase 4CompletedNCT02102815

Thammasat University100 enrolled

Overview

To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.

Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Postoperative Pain

Interventions

DexamethasoneDRUG

Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes

Normal salineDRUG

NSS 50 mL IV slowly push over 5 minutes

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty * 50-85 years old * ASA class 1-3 Exclusion Criteria: * Unable to perform spinal anaesthesia * History of drug allergies: steroids * Renal impairment (CrCl \<30 mL/min) * Liver impairment * Cognitive function disorders * Poor controlled DM (HA1C \> 7.5) * Morning DTX at operative day \> 180 mg% * Received corticosteroids within 3 months before surgery

Locations (1)

Orthopaedic department, Faculty of medicine, Thammasat university

Klongluang, Changwat Pathum Thani, Thailand

Outcomes

Primary Outcomes

post-operative pain

measured with VAS for pain, drugs for relief pain

Time frame: 48 hours

Secondary Outcomes

Functional knee score

measured with WOMAC, KSS

Time frame: 3 month

post-operative nausea and vomiting

measured with amount of nausea/vomiting and drugs requiring for fixed its.

Time frame: 48 hours

complication of preoperative dexamethasone

measured with wound complication, blood sugar level

Time frame: 2 weeks

inflammatory level

CRP level

Time frame: 48 hours

Data from ClinicalTrials.gov

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