How Variations in Pharmacogenomic Profiles Affect Pain and Narcotic Needs Following Total Knee Arthroplasty (TKA)

NorthShore University HealthSystem

Status: Completed

Conditions: Total Knee Arthroplasty (TKA); Knee Osteoarthritis

Treatments: Other: Pain Scale/Medication Log

Study type: Observational

Funder types: Other

Identifiers

NCT04020471

EH19-023

Details and patient eligibility

About

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement.

Full description

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement. People experience pain differently. The type and amount of medication required to control pain varies. Post-operative pain often requires narcotics to keep patients comfortable. It has been shown that there is a genetic difference in how people respond to pain and how they respond to the medications used for the relief of pain. Opioids are often used to relieve pain after surgery. These medications can be abused and have had a role in the current opioid crisis.

Pharmacogenomics is the study of how patients respond to and metabolize drugs and medications based on their genetic profiles. This study will collect data on the pain experienced by participants and the narcotics used after total knee replacements. This will be correlated with the participants' pharmacogenomic profiles obtained though DNA testing. There are no treatment interventions in this study. Although a pharmacogenomic profile will be obtained at the first post-operative visit and reported approximately 3 weeks later, the subject will have completed the need for pain relief. The study is expected to last 2 years with 300 subjects enrolled.

Enrollment: 375 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Unilateral primary Total Knee Arthroscopy (TKA)
• Knee Osteoarthritis
• Planned discharge to home

Exclusion criteria

• Unicompartmental Total Knee Arthroscopy (TKA)
• Revision Total Knee Arthroscopy (TKA)
• Knee flexion contracture > 15°
• Axial deformity > 15°
• Previous or current chronic narcotic use for pain > 3 months
• Previous or current substance abuse
• Any chronic pain condition
• Any dementia or cognitive disorder
• Discharge to Skilled Nursing Facility
• Rheumatoid arthritis
• Potential difficulty completing daily pain scores and medication use
• Previous NorthShore genotyping
• Currently taking CYP2D6 inhibitors (list in appendix)
• Currently taking CYP2D6 inducers (list in appendix)

Trial design

375 participants in 1 patient group

Experimental

Description:

All subjects who have completed their standard of care total knee arthroplasty will undergo pharmacogenomics testing and will complete a daily pain and medication diary for 30 days post discharge from the hospital. Subjects will be offered a consultation visit with a member of the Pharmacogenomics Team to discuss results.

Treatment:

Other: Pain Scale/Medication Log