High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain

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 Hip-surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.

Timeline

Start: 2019-01-29
Primary completion: 2021-01-01
Completion: 2021-01-01

Outcome

Missed primary endpoint

paper CONCLUSION: 1 mg kg -1vs. 0.3 mg kg -1 dexamethasone improved neither postoperative pain nor recovery in THA in a cohort of predicted high pain responders. PMID 37166257 ↗

paper 33/42 (44%) vs. 32/43 (43%), relative risk = 1.04 (95% confidence interval 0.72-1.51; P = 0.814) PMID 37166257 ↗

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 high pain responders undergoing total hip arthroplasty: A randomized controlled trial. Eur J Anaesthesiol. 2023 Oct 1;40(10):737-746. doi: 10.1097/EJA.0000000000001853. Epub 2023 May 11.

Drugs

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