DEX-2-TKA - analgesic efficacy and safety of one or two doses of steroid (dexamethsone) after total knee arthroplasty

Phase 1

• Conditions: Postoperative pain after total knee arthroplasty; MedDRA version: 20.0Level: PTClassification code 10023469Term: Knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001099-39-DK
• Lead Sponsor: aestved Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

•Scheduled for unilateral, primary TKA, not Oxford (uni-knee”).
•Age = 18
•ASA 1-3
•BMI = 18.0 and = 40.0
•Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
•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 186
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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 medication used in the trial
•Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
•Patients with at daily use of systemic glucocorticoids
•Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
•Dysregulated diabetes (investigators judgement)
•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 efficacy and safety of one or two doses of dexamethasone after total knee arthroplasty;Secondary Objective: Not applicable;Primary end point(s): Total need for i.v.-equivalent morphine for the first 48 hours postoperatively administered as patient controlled analgesia (PCA) morphine (0-24 hours), on demand oral morphine (24-48 hours) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively after end of surgery (general anaesthesia) or end of spinal anaesthesia. ;Timepoint(s) of evaluation of this end point: i.v.-equivalent morphine for the first 48 hours postoperatively