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Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response

NCT05563155 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

  • Post Operative Pain, Acute

Interventions

DRUG

Dexamethasone 24 mg

Dexamethasone 24 mg on day 1 after surgery.

DRUG

Placebo

Placebo tablet given on day 1 after surgery.

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-03-22
Completion
2024-03-22

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563155 on ClinicalTrials.gov