Perioperative management of a group of High Pain Responders in total knee-arthroplasty because of kneeosteoarthritis MedDRA version: 20.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10003398 Term: Arthroplasty of knee System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative p
Conditions
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/
Sponsors
Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.
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. - 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| 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: Individualy | — |
Countries
Denmark
Contacts
Public ContactResearch group.
Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark
Outcome results
None listed