The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery.

The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery. - The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002251-13-FI

Enrollment

Registered

2016-10-20

Start date

2016-11-09

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Patients with arthrosis of knee joint needing operative treatment i.e. arthroplasty of knee.

Interventions

Trade Name: Oradexon Pharmaceutical Form: Injection Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Pharmaceutical form of the placebo: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients having primary knee arthroplasty - age 18 years or older - ASA (American society of anesthesiologists) class 1-3 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: -coronary artery disease with severe symptoms, heart- or kidney failure - insulin dependent diabetes mellitus or poorly controlled diabetes - peptic ulcer - allergy or contraindication to any of medications used in the study - enteral/parenteral use of glucocorticoids during the last three months before the operation - opioids usage before the operation at home (other than codeine, tramadol) - neuropathy of lower limbs - lack of co-operation - inability to use the PCA-device

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to find out if single-dose intravenous dexamethasone alleviates postoperative dynamic (during walking) pain during the first two days after total knee replacement surgery.;Secondary Objective: Effects on postoperative pain at rest, consumption of oxycodone, nausea/vomiting, "wellbeing" and time to hospital discharge are studied. The extent of postoperative inflammatory reaction is observed. Possible side-effects of dexamethasone are studied: blood glucose measurement, quality of sleep, wound healing and wound infection.;Primary end point(s): Dynamic pain during walking/standing 24 h postoperatively. Measured on numeric rating scale (NRS) 0-10, where 0 is no pain and 10 is the worst pain imaginable.;Timepoint(s) of evaluation of this end point: 24 h postoperatively	—

Measure

Time frame

Main Objective: The objective of the trial is to find out if single-dose intravenous dexamethasone alleviates postoperative dynamic (during walking) pain during the first two days after total knee replacement surgery.;Secondary Objective: Effects on postoperative pain at rest, consumption of oxycodone, nausea/vomiting, "wellbeing" and time to hospital discharge are studied. The extent of postoperative inflammatory reaction is observed. Possible side-effects of dexamethasone are studied: blood glucose measurement, quality of sleep, wound healing and wound infection.;Primary end point(s): Dynamic pain during walking/standing 24 h postoperatively. Measured on numeric rating scale (NRS) 0-10, where 0 is no pain and 10 is the worst pain imaginable.;Timepoint(s) of evaluation of this end point: 24 h postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): - dynamic pain (NRS 0-10) on the day of operation, 48 h postoperatively, seventh day postoperatively -pain at rest (NRS 0-10) day of operation (recovery room, evening), first postoperative day (24 h postoperatively, evening), second postoperative day (48 h postoperatively), seventh day postoperatively - consumption of oxycodone (mg) 0-24 h, 0-48 h -nausea (NRS 0-10) day of operation, first postoperative day, second postoperative day - vomiting +/- day of operation, first postoperative day, second postoperative day -general wellbeing (NRS 0-10) first postoperative day, second postoperative day - quality of sleep (NRS 0-10) first postoperative night, second postoperative night - time to achieving discharge criteria (hrs after operation) - blood glucose (intraoperatively, recovery room, first and second postoperative day, additional measurements as necessary for treatment) - C-reactive proteiini (CRP) first and second postoperative morning - urinary retention +/- ;Timepoint(s) of evaluation of this end point: see E.5.2	—

Measure

Time frame

Secondary end point(s): - dynamic pain (NRS 0-10) on the day of operation, 48 h postoperatively, seventh day postoperatively -pain at rest (NRS 0-10) day of operation (recovery room, evening), first postoperative day (24 h postoperatively, evening), second postoperative day (48 h postoperatively), seventh day postoperatively - consumption of oxycodone (mg) 0-24 h, 0-48 h -nausea (NRS 0-10) day of operation, first postoperative day, second postoperative day - vomiting +/- day of operation, first postoperative day, second postoperative day -general wellbeing (NRS 0-10) first postoperative day, second postoperative day - quality of sleep (NRS 0-10) first postoperative night, second postoperative night - time to achieving discharge criteria (hrs after operation) - blood glucose (intraoperatively, recovery room, first and second postoperative day, additional measurements as necessary for treatment) - C-reactive proteiini (CRP) first and second postoperative morning - urinary retention +/- ;Timepoint(s) of evaluation of this end point: see E.5.2

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Countries

Finland

Contacts

Public ContactOulu university hospital

Oulu university hospital

matti.kyllonen@ppshp.fi

Outcome results

None listed

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