Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

NCT ID: NCT05008367

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-14

Study Completion Date

2020-06-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

24 mg intravenous Dexamethasone (6 ml)

Treatment B

24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

24 mg intravenous Dexamethasone (6 ml)

Isotonic saline

Intervention Type DRUG

6 ml of isotonic saline

Placebo

Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

6 ml of isotonic saline

Interventions

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Dexamethasone

24 mg intravenous Dexamethasone (6 ml)

Intervention Type DRUG

Isotonic saline

6 ml of isotonic saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participation in the DEX-2-TKA-trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gildhøj Privathospital

Brøndby, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Sjællands Universitetshospital, Køge

Køge, , Denmark

Site Status

Næstsved Sygehus

Næstved, , Denmark

Site Status

Odense Universitetshospital

Odense, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SM1-KAKG-2021

Identifier Type: -

Identifier Source: org_study_id

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