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

Highdose Steroid for High Pain Responders undergoing Total Hip-arthroplasty - A randomized doubleblindet controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002636-25-DK

Enrollment

160

Registered

2018-08-27

Start date

2018-10-23

Completion date

Unknown

Last updated

2021-07-21

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

Conditions

Perioperative management of total hip-arthroplasty because of hip-osteoarthritis MedDRA version: 20.0 Level: PT Classification code 10020096 Term: Hip 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 MedDRA version: 20.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867

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 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

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 hip-arthroplasty in a High Pain responder cohort.;Secondary Objective: To investigate the reasons for resumed hospitalization in the days after total hip-arthroplasty.;Primary end point(s): The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total hip-arthroplasty.;Timepoint(s) of evaluation of this end point: 24 hour postoperatively	—

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 hip-arthroplasty in a High Pain responder cohort.;Secondary Objective: To investigate the reasons for resumed hospitalization in the days after total hip-arthroplasty.;Primary end point(s): The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total hip-arthroplasty.;Timepoint(s) of evaluation of this end point: 24 hour 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 hip-arthroplasty. - 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	—

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 hip-arthroplasty. - 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

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Countries

Denmark

Contacts

Public ContactResearch group

Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.

Niklas.Ingemann.Nielsen@regionh.dk+4538623862

Outcome results

None listed

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