High-Dose Steroid for Knee Arthroplasty

Phase 4 Completed 160 enrolled Copenhagen University Hospital, Hvidovre Sygehus Lillebaelt · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on postoperative pain and postoperative inflammation.

Timeline

Start: 2019-01-29
Primary completion: 2022-02-01
Completion: 2022-02-01

Outcome

Missed primary endpoint

paper No difference was found between groups in the incidence of subjects experiencing visual analogue scale >30 on ambulation 24 h after surgery PMID 36526481 ↗

Publications

Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose dexamethasone in low pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2023 Mar;130(3):322-330. doi: 10.1016/j.bja.2022.10.038. Epub 2022 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	0.3 mg/kg	Intravenous
Subject	Dexamethasone	Small molecule	1 mg/kg	Intravenous