Joint Diseases
Conditions
Keywords
Arthroplasty, Replacement, Knee, Analgesics, Administration and dosage, Knee, Postoperational care, Pain management
Brief summary
This study will provide knowledge about the use of long-acting opioids for pain relief after primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone and placebo for effect on pain relief and side effects. The three study groups reflect the three different postoperative pain regimens that have been used the last years at St. Olavs Hospital, so investigators know that no patient will receive an inadequate pain treatment. The purpose of the study is to find which of the three treatments that gives the best pain relief with the least amount of side effects. The results will be of use for postoperative pain treatment for knee arthroplasty, but also for other types of major surgery. Similar studies that are not sponsored by pharmaceutical industry have not been published yet.
Interventions
DRUGTapentadol
DRUGOxycodone
DRUGPlacebo
DRUGusual pain treatment
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
Sponsors
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled for knee arthroplasty at St. Olavs University Hospital * consent in participation in the study
Exclusion criteria
* Contraindications for any of the study drugs * Lactose intolerance * Known hypersensitivity against any of the additives * Chronic Obstructive Pulmonary Disease (COPD) grade 3 or 4 * Paralytic ileus * Known alcohol or medical addiction/abuse * History of asthma, urticaria or allergic reaction caused by acetyl salicylic acid or other NSAIDs * Peptic ulcer * Hemophilia * Gastrointestinal bleeding * Cerebrovascular bleeding * Inflammatory bowel disease (ulcerous colitis, Crohn disease) * Concomitant use of the following drugs: ACE-inhibitors, AT2-blockers, SSRI, Anti-psychotic drugs, MAO-inhibitors, Atazanavir and Nelfinavir (medicine used for HIV-infection) * Known kidney failure (creatinin level above reference value) * Known heart failure (NYHA III-IV) * Pregnancy * Women in fertile age with risk of pregnancy * Nursing women * operated under general anesthesia without use of spinal anesthesia * using opioids on a regular basis except users of codeine or tramadol, or known former abuse of opioids * Cognitive failure or other factors which make follow up impossible (for example language difficulties) * No cell phone or internet connection at home (making follow up difficult)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days | 8 days | NRS-scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
| worst pain in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
| quality of sleep in the previous night | 8 days | NRS-scores 1-10 scale |
| headache | 8 days in the previous 24 hours | NRS-scores 1-10 scale |
| obstipation in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
| dizziness in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
| sedation in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
| nausea in the previous 24 hours | 8 days | NRS-scores 1-10 scale |
Countries
Norway
Outcome results
None listed