Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

NCT ID: NCT02102815

Last Updated: 2019-01-15

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Postoperative Pain

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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Dexamethasone

Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Placebo

Preoperative intravenous normal saline 50 mL slowly push over 5 minutes

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

NSS 50 mL IV slowly push over 5 minutes

Interventions

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Dexamethasone

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

Intervention Type DRUG

Normal saline

NSS 50 mL IV slowly push over 5 minutes

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Supakit Kanitnate

Orthopaedics department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Supakit Kanitnate, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedics department, Thammasat University

Locations

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Orthopaedic department, Faculty of medicine, Thammasat university

Klongluang, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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OrthoTU06

Identifier Type: -

Identifier Source: org_study_id

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