ong acting strong pain killers after knee replacement surgery. Acomparison of three different treatments.

Phase 1

• Conditions: Pain therapy for total knee arthroplasty (total knee replacement); MedDRA version: 18.0Level: LLTClassification code 10036286Term: Post-operative painSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000295-94-NO
• Lead Sponsor: St Olavs University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-24
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients scheduled for primary total knee arthroplasty
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Contra indications against any of the study drugs
Kidney failure (creatinin above reference value)
Heart failure (NYHA III-IV)
Pregnant women
Age above 80 years
Age below 18 years
Operation performed with only general anaesthesia
Unable to answer
No cell-phone/internet connection (follow-up not possible)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the trial is to measure variations in pain relief<br>between three different pain treatments;Secondary Objective: Secondary objectives are to measure variations in side effects between<br>three different pain treatments;Primary end point(s): Pain (numeric rating scale) at movement;Timepoint(s) of evaluation of this end point: Every day after the operation for 8 days, same point of time every day<br>(actual hour of the day chosen by the patient but must be registered before 12.00)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain at rest (NRS)<br>Average pain last 24 hours (NRS)<br>Worst pain last 24 hours (NRS)<br>Nausea last 24 hours (NRS)<br>Dizziness last 24 hours (NRS)<br>Constipation (NRS)<br>Sedation (NRS)<br>Headache (NRS)<br>Sleep quality (NRS)<br>Study medication taken (Yes/No)<br>Amount of rescue medication (IR oxycodone);Timepoint(s) of evaluation of this end point: Every day after the operation for 8 days, same point of time every day<br>(actual hour of the day chosen by the patient but must be registered before 12.00)