Highdose steroids in a High Pain Responder-group undergoing total knee-replacement surgery - A lottery-based doubleblindet controlled trial.

Phase 1

• Conditions: Perioperative management of a group of High Pain Responders in total knee-arthroplasty because of kneeosteoarthritis; MedDRA version: 20.0Level: PTClassification code 10023469Term: Knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10003398Term: Arthroplasty of kneeSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-002635-23-DK
• Lead Sponsor: Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-18
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

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.
- Chronic opioid-user with >29 mg morfine/day or equivalent other opioids and/or Pain Catastrophizing Scale-score of >20.
- 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

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.
- A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of high dose steroids on the amount of patients with VAS >30 in a 5-meter walktest, 24 hours postoperatively efter total kneearthroplasty in a High Pain responder cohort.;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

Secondary Outcome Measures

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