drugset / Trial / NCT02604446

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

NCT02604446 ↗

Phase 3 Completed 134 enrolled St. Olavs Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2019-02
Completion
2019-02

Outcome

Missed primary endpoint

paper Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo. PMID 32773594 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified 10 mg —
Subject Tapentadol Small molecule 50 mg —
Background Acetaminophen Small molecule — —
Background Dexamethasone Small molecule — —
Background VIMOVO Unknown — —