Post operative pain after total knee replacement MedDRA version: 12.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief
Conditions
Interventions
Trade Name: oxyContin
Pharmaceutical Form: Tablet
INN or Proposed INN: OXYCODONE
CAS Number: 76426
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-10
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient of at least 18 years or older who are sheduled for a total knee prosthesis Are the trial subjects under 18? 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A history of hypersensitivity to oxycodone, patients receiving opiod substitution therapy for opioid addiction patients receiving opioid treatment for chronic pain or cancer pain before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of oxycodone;Secondary Objective: to asses adverse events;Primary end point(s): The absolute change at postoperative day 8 from baseline (ie postoperative day 1) of the average daily NRS score. | — |
Countries
Belgium
Outcome results
None listed