NCT02604446

Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo

Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty. A Double Blinded Randomized Controlled Study. Tapentadol vs Oxycodone vs Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Joint Diseases

Interventions

Type	Name	Description
DRUG	Tapentadol
DRUG	Oxycodone
DRUG	Placebo
DRUG	usual pain treatment	premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2015-11-13
• Last updated: 2021-11-16

Locations

1 site across 1 country: Norway