An interventional study of Standard care and Multicomponent opioid reduction and pain management pathway in Knee Arthroplasty, Total, Partial Knee Arthroplasty and Chronic Pain, Postoperative, sponsored by McMaster University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 170 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →McMaster University is the lead sponsor of 739 studies on the registry; 126 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive standard perioperative care, surgical treatment, and pain medications.
Other: Standard care
Patients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component.
Other: Standard care · Other: Multicomponent opioid reduction and pain management pathway
Standard perioperative care, surgical treatment, and pain medications.
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.
Chronic postsurgical pain
Chronic postsurgical pain is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded.
Time frame: 3 months after surgery
Moderate-to-severe chronic postsurgical pain
Chronic postsurgical pain is defined as per the definition adopted in International Classification of Diseases version 11; mild-to-moderate is defined as pain intensity of ≥4/10 during ambulation over the last week
Time frame: 3, 6, 9, and 12 months after surgery
Pain control
Time to achieve good pain control; good pain control will be defined as achieving a state of pain intensity of \<4/10 during ambulation over the past week without the need for daily opioid medication for the operated knee.
Time frame: Up to 3 months after surgery
Chronic postsurgical pain
Chronic postsurgical pain is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded.
Time frame: 6, 9, and 12 months after surgery
Persistent opioid use
Presence of persistent opioid use, based on patient reporting indicating the need for daily opioid use that started after surgery or increased after surgery (binary).
Time frame: 3, 6, 9, and 12 months after surgery
Chronic postsurgical pain intensity
Average intensity of chronic postsurgical pain at rest and with movement. Measured on a 0-10 numeric rating scale.
Time frame: 3, 6, 9, and 12 months after surgery
Satisfaction with pain control
Using a 0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)
Time frame: 3, 6, 9, and 12 months after surgery
Knee function
Using the 12-item Oxford Knee Score to assess knee function and pain following a total knee replacement.
Time frame: 3, 6, 9, and 12 months after surgery
Quality of life
Measured using Euro-Qol 5 dimensions scale consisting of 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression,
Time frame: 3, 6, 9, and 12 months after surgery
Adverse events
Operative and knee-related complications, pain medication related adverse events, readmissions, and all serious adverse events
Time frame: From baseline to 12 months after surgery
Health economics
Euro-Qol 5 dimensions scale will be used 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
Time frame: From baseline to 12 months after surgery
No study locations are listed for this record.
Plan to share: Yes — De-identified trial data
Supporting information: Study protocol, Statistical analysis plan
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact Dr. Kim Madden at maddenk@mcmaster.ca
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Mar 2029, 25 months later.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 25 months is above that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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