A lottery trial for patients at increased risk of pain operated on with the insertion of artificial knees. After the operation, the draw will take place and the patient will either receive the active treatment, 1 tablet 24 mg. Dexamethasone / adrenocortical hormone or placebo tablet / not active treatment.

Repeat dose steroid to prevent pain relapse after Total Knee Arthroplasty in patients with high pain response - A randomized blinded placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006110-20-DK

Enrollment

100

Registered

2021-03-31

Start date

2021-06-18

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Periooperative 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: Dexamethason Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE ACEFURATE CAS Number: 83880-70-0 INN or Proposed INN: DEXAMETHASONE CAS Number: 312-93-6 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Age > 40 • Primary unilateral TKA • Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction). • Signed written informed consent form • PCS >20 • Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test in the morning the first day after surgery between 8 am and 12 am (16-26 hours postoperatively). 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 70

Exclusion criteria

Exclusion criteria: Exclusion criteria • Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids. • Insulin-dependent diabetes. • Pregnancy or breastfeeding.* • Allergies concerning the study-drug. • Mental disability that could impair a patient’s decision-making capability of giving informed consent and not enabling valid data collection. • Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment. • Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders. *Pregnancy: No women with suspected or proven pregnancy is eligible for inclusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after TKA in an HPR population to a standard single high dose systemic preoperative administration in an HPR population. ;Secondary Objective: x;Primary end point(s): Moderate to severe pain (VAS > 30) upon ambulation in a 5-meter walk test, on the morning of day 2 after TKA surgery. ;Timepoint(s) of evaluation of this end point: 48 hours postoperatively	—

Measure

Time frame

Main Objective: The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after TKA in an HPR population to a standard single high dose systemic preoperative administration in an HPR population. ;Secondary Objective: x;Primary end point(s): Moderate to severe pain (VAS > 30) upon ambulation in a 5-meter walk test, on the morning of day 2 after TKA surgery. ;Timepoint(s) of evaluation of this end point: 48 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): • Cumulated pain upon ambulation in a 5-meter walk test day 2-3. • Cumulated pain score at rest, walking and at night from day 2-7. • Quality of sleep, pre- and postoperatively from day 0 to day 7. • Cumulative use of rescue-analgesics per day in hospital day 0 to discharge, and at home from day of discharge to day 7. • Patient satisfaction with analgesic-regimen at day 7. • Length of stay (LOS) in hospital, and reasons for prolonged stay (>2 postoperative days). • Reasons for re-admissions within 30 days. • Morbidity and mortality (30-day follow-up by Electronic patient journal or telephone). ;Timepoint(s) of evaluation of this end point: Indicidual	—

Measure

Time frame

Secondary end point(s): • Cumulated pain upon ambulation in a 5-meter walk test day 2-3. • Cumulated pain score at rest, walking and at night from day 2-7. • Quality of sleep, pre- and postoperatively from day 0 to day 7. • Cumulative use of rescue-analgesics per day in hospital day 0 to discharge, and at home from day of discharge to day 7. • Patient satisfaction with analgesic-regimen at day 7. • Length of stay (LOS) in hospital, and reasons for prolonged stay (>2 postoperative days). • Reasons for re-admissions within 30 days. • Morbidity and mortality (30-day follow-up by Electronic patient journal or telephone). ;Timepoint(s) of evaluation of this end point: Indicidual

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Countries

Denmark

Contacts

Public ContactForskningsenheden Ortopædkirurgisk

Ortopædkirurgisk Department. Vejle Sygehus. Denmark

clausvarnum@gmail.com+4579405779

Outcome results

None listed

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