NCT02711592

Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study

Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to see how pain management and its outcomes are effected when pharmacogenomic testing is used to determine patient specific pain medication and dosing. Our goal is to determine if through the use of analgesic genetic testing, TKA post-operative patients will see a decrease in narcotic consumption, postsurgical opioid- related adverse reactions, and length of stay, overall NRS pain scores and while maintaining or improving their satisfaction scores.

Detailed description

This is a pilot study that will look at how pain management will be effected when pharmacogenomic testing is utilized to select and dose narcotic pain medications prescribed for breakthrough pain in post-operative total knee arthroplasty (TKA) patients. Patients will receive individualized analgesics and doses for pain mitigation based on genetic testing results. Post op pain scores, narcotic consumption, adverse reactions, length of stay and patient satisfaction with pain management will be collected and analyzed to determine the significance of the pharmacogenomic analgesic testing. Due to the lack of literature and evidence surrounding pharmacogenomics and its use in selecting analgesics to control post-operative pain a pilot study is being conducted to evaluate effect size (statistical variability) in an attempt to predict an appropriate sample size for a larger scale randomized control trial. The subjects enrolled and data collected for this internal pilot will be used in the larger scale parent study as well.

Conditions

• Arthroplasty, Replacement, Knee
• Pain, Postoperative

Interventions

Type	Name	Description
GENETIC	Genetic Panel for Analgesics	All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.

Timeline

• Start date: 2016-10-05
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2016-03-17
• Last updated: 2021-02-25

Locations

1 site across 1 country: United States