search
Back to results

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Isotonic saline
Sponsored by
Naestved Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participation in the DEX-2-TKA-trial

Sites / Locations

  • Gildhøj Privathospital
  • Bispebjerg Hospital
  • Sjællands Universitetshospital, Køge
  • Næstsved Sygehus
  • Odense Universitetshospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Treatment A

Treatment B

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 13, 2021
Last Updated
September 6, 2021
Sponsor
Naestved Hospital
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05008367
Brief Title
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
Official Title
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
June 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naestved Hospital
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
24 mg intravenous Dexamethasone (6 ml)
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
6 ml of isotonic saline
Primary Outcome Measure Information:
Title
Cumulative usage of morphine 0-48 hours postoperatively
Description
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
Time Frame: 0-48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Subgroup analysis on heterogeneity in intervention effect of age
Description
Age (years): > 65 vs. ≤ 65
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of sex
Description
Sex: male vs. female
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of ASA group
Description
ASA group classification: I+II vs. III
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest
Description
VAS (mm): > 30 vs. ≤ 30
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active
Description
VAS (mm): > 30 vs. ≤ 30
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of type of anesthesia
Description
Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia
Time Frame
Time Frame: 0-48 hours postoperatively
Title
Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication
Description
Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID
Time Frame
Time Frame: 0-48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in the DEX-2-TKA-trial
Facility Information:
Facility Name
Gildhøj Privathospital
City
Brøndbyvester
ZIP/Postal Code
2605
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Sjællands Universitetshospital, Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Næstsved Sygehus
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

We'll reach out to this number within 24 hrs