NCT04244695

Brief Summary

To compare efficacy of oral steroid in controlling pain after TKA

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 24, 2020

Last Update Submit

January 24, 2020

Conditions

Pain, Acute

Keywords

oral corticosteroidpostoperative paindexamethasonetotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Pain level

    VAS for pain (0-100) at rest and on motion

    12, 24 ,36, 48, 60 and 72 hours after surgery

Secondary Outcomes (6)

  • nausea and vomiting

    in the first 72 hours after surgery

  • Range of motion of the knee

    24, 72 hours then 2, 6, 12 weeks after surgery

  • Functional outcome

    2, 6,12 weeks after surgery

  • Blood sugar

    At 8.00 am of 1, 2, 3 days after surgery

  • inflammatory level

    At 8.00 am of 1, 2, 3 days and 2 weeks after surgery

  • +1 more secondary outcomes

Study Arms (3)

Dexamethasone 16 mg

EXPERIMENTAL

Dexamethasone (4mg) 4 tab oral once daily in the morning

Drug: Dexamethasone Oral

Dexamethasone 8 mg

ACTIVE COMPARATOR

Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning

Drug: Dexamethasone Oral

Placebo

PLACEBO COMPARATOR

Placebo 4 tab oral once daily in the morning

Drug: Dexamethasone Oral

Interventions

Dexamethasone OralDRUG

To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Dexamethasone 16 mgDexamethasone 8 mgPlacebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with osteoarthritis of the knee who undergoing unilateral TKA
  • ASA class I-III
  • Informed consent
  • Good cognitive function

You may not qualify if:

  • Uncontrolled DM (HbA1C \> 7)
  • Uncontrolled HT
  • Morbid obesity (BMI \> 40)
  • History of bleeding in GI tract
  • Corticosteroid used within 6 months
  • Sever liver or renal impairments
  • Studied drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, 066, Thailand

RECRUITING

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
membership

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)