Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
1 other identifier
interventional
485
1 country
5
Brief Summary
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 postoperative-pain
Started Sep 2018
Typical duration for phase_4 postoperative-pain
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2020
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedSeptember 13, 2021
September 1, 2021
1.5 years
July 13, 2021
September 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative usage of morphine 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
Time Frame: 0-48 hours postoperatively
Other Outcomes (7)
Subgroup analysis on heterogeneity in intervention effect of age
Time Frame: 0-48 hours postoperatively
Subgroup analysis on heterogeneity in intervention effect of sex
Time Frame: 0-48 hours postoperatively
Subgroup analysis on heterogeneity in intervention effect of ASA group
Time Frame: 0-48 hours postoperatively
- +4 more other outcomes
Study Arms (3)
Treatment A
ACTIVE COMPARATOR24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
Treatment B
ACTIVE COMPARATOR24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Placebo
PLACEBO COMPARATORPlacebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Interventions
Eligibility Criteria
You may qualify if:
- Participation in the DEX-2-TKA-trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Gildhøj Privathospital
Brøndby, 2605, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Sjællands Universitetshospital, Køge
Køge, 4600, Denmark
Næstsved Sygehus
Næstved, 4700, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- SPONSOR
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 17, 2021
Study Start
September 14, 2018
Primary Completion
March 11, 2020
Study Completion
June 7, 2020
Last Updated
September 13, 2021
Record last verified: 2021-09