- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05008367
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
September 6, 2021 updated by: Naestved Hospital
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
485
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
-
-
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Brøndbyvester, Denmark, 2605
- Gildhøj Privathospital
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Copenhagen, Denmark, 2400
- Bispebjerg Hospital
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Køge, Denmark, 4600
- Sjællands Universitetshospital, Køge
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Næstved, Denmark, 4700
- Næstsved Sygehus
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Odense, Denmark, 5000
- Odense Universitetshospital
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participation in the DEX-2-TKA-trial
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 |
---|---|
Active Comparator: Treatment A
24 mg dexamethasone i.v.
perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
|
24 mg intravenous Dexamethasone (6 ml)
|
Active Comparator: Treatment B
24 mg dexamethasone i.v.
perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
|
24 mg intravenous Dexamethasone (6 ml)
6 ml of isotonic saline
|
Placebo Comparator: Placebo
Placebo (isotonic saline) i.v.
perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
|
6 ml of isotonic saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative usage of morphine 0-48 hours postoperatively
Time Frame: Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subgroup analysis on heterogeneity in intervention effect of age
Time Frame: Time Frame: 0-48 hours postoperatively
|
Age (years): > 65 vs. ≤ 65
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of sex
Time Frame: Time Frame: 0-48 hours postoperatively
|
Sex: male vs. female
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of ASA group
Time Frame: Time Frame: 0-48 hours postoperatively
|
ASA group classification: I+II vs. III
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest
Time Frame: Time Frame: 0-48 hours postoperatively
|
VAS (mm): > 30 vs. ≤ 30
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active
Time Frame: Time Frame: 0-48 hours postoperatively
|
VAS (mm): > 30 vs. ≤ 30
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of type of anesthesia
Time Frame: Time Frame: 0-48 hours postoperatively
|
Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia
|
Time Frame: 0-48 hours postoperatively
|
Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication
Time Frame: Time Frame: 0-48 hours postoperatively
|
Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID
|
Time Frame: 0-48 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 14, 2018
Primary Completion (Actual)
March 11, 2020
Study Completion (Actual)
June 7, 2020
Study Registration Dates
First Submitted
July 13, 2021
First Submitted That Met QC Criteria
August 9, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 6, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- SM1-KAKG-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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