St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
NCT Number: NCT04968132
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.
People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.
This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8N 4A6, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-operative pain education and expectation setting, identification and modification of risk factors in high risk patients, postoperative individualized analgesic prescriptions, and continued support for pan control and recovery facilitated by an interventions coordinator.
Standard perioperative care, surgical treatment, and pain medications.
Time frame: 8 weeks
Percentage of patients receiving at least 3 of the 4 trial intervention components.
Time frame: 4 months
Number of participants recruited
Time frame: 8 weeks
Number of participants completing the primary outcome
Time frame: 8 weeks
Three or more consecutive days of <4/10 pain score on a 0-10 numeric rating scale (NRS; lower score is better) with no opioid use for the operated knee.
Time frame: 12 months
Defined by the International Classification of Diseases version-11 (ICD-11) criteria
Time frame: 12 months
Measured on a 0-10 numeric rating scale (NRS; lower score is better)
Time frame: 12 months
Presence of daily opioid use, started after surgery or increased after surgery (binary)
Time frame: 12 months
0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)
Time frame: 12 months
EuroQol-5 Dimensions (EQ-5D)
Time frame: 12 months
Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions
Time frame: 12 months
Investigators will use the EQ-5D to assess health utilities for the purpose of health economic analyses (e.g., cost-effectiveness). Intervention costs and healthcare resource utilization information (e.g., hospitalization, physician visits) as well as information on productivity (e.g., time missed from work) will be collected using a self-administered questionnaire, which will be developed for the purpose of this study
Kim Madden
Other
Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
Acronym: OREOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07126340
Arthritis, Joint Diseases
Adana, University, Turkey (Türkiye)
View Trial DetailsNCT04749628
Arthritis, Joint Diseases
New York, United States
View Trial DetailsNCT07320833
Arthritis, Bites and Stings
Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT07134283
Arthritis, Cryotherapy
Ankara, Turkey (Türkiye)
View Trial Details