Use of long acting opioids for pre- and postoperative analgesia in primary

INTERVENTION: Trade Name: Palexia Depot Pharmaceutical Form: Tablet INN or Proposed INN: TAPENTADOL HYDROCHLORIDE CAS Number: 175591‐09‐0 Other descriptive name: TAPENTADOL HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Oxycontin Pharmaceutical Form: Tablet INN or Proposed INN: OXYCODONE HYDROCHLORIDE CAS Number: 124‐90‐3 Other descriptive name: OXYCODONE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Pain therapy for total knee arthroplasty (total knee replacement) ; MedDRA version: 18.0 Level: LLT Classification code 10036286 Term: Post‐operative pain System Organ Class: 100000004863 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: Primary objective of the trial is to measure variations in pain relief; between three different pain treatments Primary end point(s): Pain (numeric rating scale) at movement Secondary Objective: Secondary objectives are to measure variations in side effects between; three different pain treatments Timepoint(s) of evaluation of this end point: Every day after the operation for 8 days, same point of time every day; (actual hour of the day chosen by the patient but must be registered before 12.00) SECONDARY OUTCOME: Secondary end point(s): Pain at rest (NRS) ; Average pain last 24 hours (NRS) ; Worst pain last 24 hours (NRS) ; Nausea last 24 hours (NRS) ; Dizziness last 24 hours (NRS) ; Constipation (NRS) ; Sedation (NRS) ; Headache (NRS) ; Sleep quality (NRS) ; Study medication taken (Yes/No) ; 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 ; (actual hour of the day chosen by the patient but must be registered before 12.00) 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