Long acting strong pain killers after knee replacement surgery. A comparison of three different treatments.

Use of long acting opioids for pre- and postoperative analgesia in primary total knee arthroplasty. A double-blinded randomized control trial. Tapentadol vs Oxycodon vs Placebo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000295-94-NO

Enrollment

150

Registered

2015-06-24

Start date

2015-10-13

Completion date

Unknown

Last updated

2020-03-18

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

Conditions

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

Interventions

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 mill

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective of the trial is to measure variations in pain relief between three different pain treatments;Secondary Objective: Secondary objectives are to measure variations in side effects between 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 (actual hour of the day chosen by the patient but must be registered before 12.00)	—

Measure

Time frame

Main Objective: Primary objective of the trial is to measure variations in pain relief between three different pain treatments;Secondary Objective: Secondary objectives are to measure variations in side effects between 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 (actual hour of the day chosen by the patient but must be registered before 12.00)

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Norway

Contacts

Public ContactHead of Clinic, Orthopedic surgery

St. Olavs University Hospital

jan.gunnar.skogas@stolav.no+4772823244

Outcome results

None listed

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