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

Phase 1

• Conditions: Patients with arthrosis of knee joint needing operative treatment i.e. arthroplasty of knee.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-002251-13-FI
• Lead Sponsor: Oulu university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-20
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 96

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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