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Completed

NCT Number: NCT02102815

Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

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

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopaedic department, Faculty of medicine, Thammasat university

Klongluang, Changwat Pathum Thani, 066, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

normal saline

Drug

NSS 50 mL IV slowly push over 5 minutes

Primary outcomes

  1. post-operative pain

    Time frame: 48 hours

    measured with VAS for pain, drugs for relief pain

Secondary outcomes

  1. Functional knee score

    Time frame: 3 month

    measured with WOMAC, KSS

  2. post-operative nausea and vomiting

    Time frame: 48 hours

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

  3. complication of preoperative dexamethasone

    Time frame: 2 weeks

    measured with wound complication, blood sugar level

  4. inflammatory level

    Time frame: 48 hours

    CRP level

Other outcomes

  1. Knee range of motion

    Time frame: 3 months

    measuring range of motion with goniometer

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial

Acronym: TKA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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