Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty (TKA)

January 12, 2019 updated by: Supakit Kanitnate, Thammasat University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Klongluang, Pathumthani, Thailand, 066
        • Orthopaedic department, Faculty of medicine, Thammasat university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes
Drug: Dexamethasone
Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes
Placebo Comparator: Placebo
Preoperative intravenous normal saline 50 mL slowly push over 5 minutes
Drug: Normal saline
NSS 50 mL IV slowly push over 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain
Time Frame: 48 hours
measured with VAS for pain, drugs for relief pain
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional knee score
Time Frame: 3 month
measured with WOMAC, KSS
3 month
post-operative nausea and vomiting
Time Frame: 48 hours
measured with amount of nausea/vomiting and drugs requiring for fixed its.
48 hours
complication of preoperative dexamethasone
Time Frame: 2 weeks
measured with wound complication, blood sugar level
2 weeks
inflammatory level
Time Frame: 48 hours
CRP level
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee range of motion
Time Frame: 3 months
measuring range of motion with goniometer
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Supakit Kanitnate, M.D., Orthopaedics department, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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