Knee Injuries, Knee Injuries and Disorders, Opioid Use
Conditions
Keywords
Opioid, Total Knee Replacement, Knee Arthroplasty, Knee Injuries, Prevention, Analgesics, Opioid
Brief summary
In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.
Detailed description
The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups. There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened booster session approximately 2-weeks post-op.
Interventions
BEHAVIORALOpioid Reduction Program
Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.
Sponsors
Campbell Clinic
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription. * Access to a telephone. * Able to consent in English.
Exclusion criteria
* Under the age of 18. * Contraindications to use of opioid medication. * No access to a telephone. * Unable to understand consent materials in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid pills (dose and type) prescribed by Campbell Clinic. | 12-weeks post-op. | transcribed from medical record at Campbell Clinic |
| Opioid pills prescribed outside of Campbell Clinic. | 12-weeks post-op. | assessed via scan of prescription drug monitoring database for Tennessee |
| Opioid pill count questionnaire. | 12-weeks post-op. | self-report from participant of how many opioids are left in the bottle at the 12 week assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS Jr. | 12-weeks post-op. | There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme |
Countries
United States
Outcome results
None listed