Highdose steroid for knee replacement surgery - A lottery-based doubleblindet controlled study.

Highdose steroid for total knee arthroplasty - A randomized doubleblindet controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002634-20-DK

Enrollment

160

Registered

2018-08-27

Start date

2018-10-23

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative management of total knee-arthroplasty because of knee-osteoarthritis MedDRA version: 20.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Dexa-ratiopharm ® Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE CAS Number: 312-93-6 Other descriptive name: DEXAMETHASONE PHOSPHATE Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 40 and 90. - Booked for unilateral knee-arthroplasty. - Is able to take part in the investigation(selfreporting of pain and nausea/vomitting) - Understands Danish or English, or has a translator available. - Signatured written consent. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: - Insulin-dependent diabetes melitus. - Ongoing treatment with systemic glucocorticoids or immunesuppressing treatment(apart from inhaled glucocorticoids). - Pregnancy/Breastfeeding - Allergies for the investigational drug. - Daily use of opiods. - A pain catastrophizing scale(PCS) score of >20. - A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the amount of patients with VAS >30 in a 5-meter walk test, 24 hours postoperatively efter total kneearthroplasty.;Secondary Objective: To investigate the reasons for resumed hospitalization in the days after total knee-arthroplasty.;Primary end point(s): The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.;Timepoint(s) of evaluation of this end point: 24 hours postoperatively	—

Measure

Time frame

Main Objective: To investigate the amount of patients with VAS >30 in a 5-meter walk test, 24 hours postoperatively efter total kneearthroplasty.;Secondary Objective: To investigate the reasons for resumed hospitalization in the days after total knee-arthroplasty.;Primary end point(s): The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.;Timepoint(s) of evaluation of this end point: 24 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): - Pain upon rest and in a 5-meter walking test 4, 24 and 48 hours postoperatively, and filling out a 7 day pain-diary. - Acummulated painscore 0-48 hours postoperatively in rest and walking. - Duration of stay in PACU. - Length of stay in hospital. - "Why still in hospital"-registration at 9 hours postoperatively and 2 times daily the next 3 days. - Assesment of Opioid-related sideeffects (OR-SDS). - PONV after kneearthroplasty. - The need for, and amount of rescue analgetics during the perioperative, postoperative and reconvalescense phase until day 7. - The need for, and amount of rescue antiemetics during the perioperative, postoperative and reconvalescense phase until day 7. - The influence on the inflammatory response expressed by C-reactive protein(CRP), analysed preoperatively and 24 og 48 hours after surgery. - Quality of sleep, VAS. - Morbidity and mortality(30 and 90 days). ;Timepoint(s) of evaluation of this end point: Individual	—

Measure

Time frame

Secondary end point(s): - Pain upon rest and in a 5-meter walking test 4, 24 and 48 hours postoperatively, and filling out a 7 day pain-diary. - Acummulated painscore 0-48 hours postoperatively in rest and walking. - Duration of stay in PACU. - Length of stay in hospital. - "Why still in hospital"-registration at 9 hours postoperatively and 2 times daily the next 3 days. - Assesment of Opioid-related sideeffects (OR-SDS). - PONV after kneearthroplasty. - The need for, and amount of rescue analgetics during the perioperative, postoperative and reconvalescense phase until day 7. - The need for, and amount of rescue antiemetics during the perioperative, postoperative and reconvalescense phase until day 7. - The influence on the inflammatory response expressed by C-reactive protein(CRP), analysed preoperatively and 24 og 48 hours after surgery. - Quality of sleep, VAS. - Morbidity and mortality(30 and 90 days). ;Timepoint(s) of evaluation of this end point: Individual

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Countries

Denmark

Contacts

Public ContactResearch group, anaesthesia Dept.

Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark

Nicolai.Bang.Foss@regionH.dk+4538623862

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026