Efficacy of Preoperative Intravenous Dexamethasone in Pri... | NCT02102815

Studies
Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

NCT02102815

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Jan 15, 2019Actual

Enrollment

100Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Dexamethasone
Normal saline

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Feb 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2019

Last Update Posted Date

Jan 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Experimental	Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes	Drug: Dexamethasone
Placebo	Placebo Comparator	Preoperative intravenous normal saline 50 mL slowly push over 5 minutes	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes	Dexamethasone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Functional knee score	measured with WOMAC, KSS	3 month
post-operative nausea and vomiting	measured with amount of nausea/vomiting and drugs requiring for fixed its.

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Supakit Kanitnate, M.D.	Orthopaedics department, Thammasat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic department, Faculty of medicine, Thammasat university		Klongluang	Changwat Pathum Thani	066	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D000077330	Saline Solution

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided