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

Phase 1

• Conditions: Perioperative management of total hip-arthroplasty because of hip-osteoarthritis; MedDRA version: 20.0Level: PTClassification code 10020096Term: Hip arthroplastySystem 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: EUCTR2018-002636-25-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: 2018-08-27
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Age between 40 and 90.
- Booked for unilateral hip-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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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