Chronic Post Operative Pain, Knee Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, education, opioid reduction, cognitive behavioural therapy
Brief summary
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.
Interventions
OTHERMulticomponent opioid reduction and pain management pathway
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.
OTHERStandard care
Standard perioperative care, surgical treatment, and pain medications.
Sponsors
St. Joseph's Healthcare Hamilton
McMaster Surgical Associates
St. Joseph's Healthcare Foundation
Kim Madden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the study interventions, patients and the health care team cannot be blinded. An independent blinded surgeon will evaluate each adverse event to minimize the risk of bias for that outcome. The primary study outcome of non-opioid pain control will be collected using a daily e-diary up to 8 weeks. Other study outcomes will be collected by a research personnel not involved in the clinical care. Data analysts will be blinded for all outcomes
Intervention model description
2 group parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (18+) * Undergoing elective total knee arthroplasty (TKA) for knee arthritis * Can use a simple electronic (phone or tablet) device * Provide informed consent to participate
Exclusion criteria
* Revision surgery * Simultaneous bilateral arthroplasties * Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention [feasibility] | 8 weeks | Number of participants completing the primary outcome |
| Intervention adherence [feasibility] | 8 weeks | Percentage of patients receiving at least 3 of the 4 trial intervention components. |
| Participant recruitment [feasibility] | 4 months | Number of participants recruited |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CPSP intensity of resting and movement evoked pain | 12 months | Measured on a 0-10 numeric rating scale (NRS; lower score is better) |
| Postoperative opioid use | 12 months | Presence of daily opioid use, started after surgery or increased after surgery (binary) |
| Health related quality of life | 12 months | EuroQol-5 Dimensions (EQ-5D) |
| Complications | 12 months | Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions |
| Satisfaction with pain control | 12 months | 0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied) |
| Opioid-free pain control | 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. |
| Chronic post-surgical pain (CPSP) | 12 months | Defined by the International Classification of Diseases version-11 (ICD-11) criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health economics | 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 |
Countries
Canada
Outcome results
None listed