Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Dexamethasone; Drug: Isotonic saline

• Registration Number: NCT05008367
• Lead Sponsor: Naestved Hospital

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.

Study Timeline

• Study Start: 2018-09-14
• Primary Completion: 2020-03-11
• Study Completion: 2020-06-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

• Participation in the DEX-2-TKA-trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	Isotonic saline	24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Placebo	Isotonic saline	Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Treatment A	Dexamethasone	24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
Treatment B	Dexamethasone	24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Primary Outcome Measures

Name	Time	Method
Cumulative usage of morphine 0-48 hours postoperatively	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

Trial Locations

Locations (5)

Næstsved Sygehus; 🇩🇰 Næstved, Denmark

Gildhøj Privathospital; 🇩🇰 Brøndbyvester, Denmark

Sjællands Universitetshospital, Køge; 🇩🇰 Køge, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark