Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008367
• Other study ID #: SM1-KAKG-2021
• Status: Completed
• Phase: Phase 4
• Start date: September 14, 2018
• Est. completion date: June 7, 2020

Study information

• Verified date: September 2021
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: June 7, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in the DEX-2-TKA-trial

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
24 mg intravenous Dexamethasone (6 ml)
• Isotonic saline
6 ml of isotonic saline

Locations

Country	Name	City	State
Denmark	Gildhøj Privathospital	Brøndbyvester
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Sjællands Universitetshospital, Køge	Køge
Denmark	Næstsved Sygehus	Næstved
Denmark	Odense Universitetshospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Naestved Hospital	Copenhagen Trial Unit, Center for Clinical Intervention Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis on heterogeneity in intervention effect of age	Age (years): > 65 vs. = 65	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of sex	Sex: male vs. female	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of ASA group	ASA group classification: I+II vs. III	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest	VAS (mm): > 30 vs. = 30	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active	VAS (mm): > 30 vs. = 30	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of type of anesthesia	Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia	Time Frame: 0-48 hours postoperatively
Other	Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication	Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID	Time Frame: 0-48 hours postoperatively
Primary	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