DEXRAR - analgesic efficacy and safety of a single dose steroid (dexamethasone) after revision surgery of knee replacement

Phase 1

Conditions: Pain after revision surgery after total knee replacement
MedDRA version: 19.0Level: LLTClassification code 10057129Term: Revision of total knee arthroplastySystem Organ Class: 100000004865
MedDRA version: 19.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-002769-72-DK

Lead Sponsor: æstved Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
•Age > 18
•ASA 1- 3.
•BMI > 18 and < 45
•Women in the fertile age (i.e. until one year after menopause) must have negative urine HCG pregnancy test
•Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Patients who cannot cooperate with the trial.
•Concomitant participation in another trial involving medication
•Patients who cannot understand or speak Danish.
•Patients with allergy to medicines used in the trial.
•Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
•Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to investigate the analgesic effect of dexamethasone (glucocorticoids) after revision-total knee arthroplasty.;Secondary Objective: Not applicable;Primary end point(s): •Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administred at the post-anaesthesia unit the first hour postoperatively ;Timepoint(s) of evaluation of this end point: Morphine consumption at 24 hours post surgery

Secondary Outcome Measures