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NCT Number: NCT05008367

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gildhøj Privathospital, Brøndby, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in the DEX-2-TKA-trial

Treatment and study plan

Dexamethasone

Drug

24 mg intravenous Dexamethasone (6 ml)

Isotonic saline

Drug

6 ml of isotonic saline

Primary outcomes

  1. 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

Other outcomes

  1. Subgroup analysis on heterogeneity in intervention effect of age

    Time frame: Time Frame: 0-48 hours postoperatively

    Age (years): > 65 vs. ≤ 65

  2. Subgroup analysis on heterogeneity in intervention effect of sex

    Time frame: Time Frame: 0-48 hours postoperatively

    Sex: male vs. female

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

Registry information

Official study title

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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