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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Dexamethasone

Normal saline

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring total knee arthroplasty, pain control, dexamethasone, steroids

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopaedic department, Faculty of medicine, Thammasat university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

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

Preoperative intravenous normal saline 50 mL slowly push over 5 minutes

Outcomes

Primary Outcome Measures

post-operative pain

measured with VAS for pain, drugs for relief pain

Secondary Outcome Measures

Functional knee score

measured with WOMAC, KSS

post-operative nausea and vomiting

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

complication of preoperative dexamethasone

measured with wound complication, blood sugar level

inflammatory level

CRP level

Full Information

NCT ID

NCT02102815

First Posted

March 31, 2014

Last Updated

January 12, 2019

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT02102815

Brief Title

Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

Acronym

TKA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

total knee arthroplasty, pain control, dexamethasone, steroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Preoperative intravenous normal saline 50 mL slowly push over 5 minutes

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

NSS 50 mL IV slowly push over 5 minutes

Primary Outcome Measure Information:

Title

post-operative pain

Description

measured with VAS for pain, drugs for relief pain

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Functional knee score

Description

measured with WOMAC, KSS

Time Frame

3 month

Title

post-operative nausea and vomiting

Description

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

Time Frame

48 hours

Title

complication of preoperative dexamethasone

Description

measured with wound complication, blood sugar level

Time Frame

2 weeks

Title

inflammatory level

Description

CRP level

Time Frame

48 hours

Other Pre-specified Outcome Measures:

Title

Knee range of motion

Description

measuring range of motion with goniometer

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Supakit Kanitnate, M.D.

Organizational Affiliation

Orthopaedics department, Thammasat University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthopaedic department, Faculty of medicine, Thammasat university

City

Klongluang

State/Province

Pathumthani

ZIP/Postal Code

066

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

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