At a glance
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Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
In Brief
A Phase 4 clinical trial evaluating Dexamethasone 24 mg and Placebo for Post Operative Pain, Acute. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population. As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA. The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.
Study Details
Timeline
Interventions
Dexamethasone 24 mg on day 1 after surgery.
Placebo tablet given on day 1 after surgery.