Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT02711592|
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee Pain, Postoperative||Genetic: Genetic Panel for Analgesics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Genetic Panel for Analgesics
Genetic testing for analgesics prior to surgery will be conducted. The subject will receive postoperative analgesia based on test results.
Genetic: Genetic Panel for Analgesics
All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.
- Pain Scores [ Time Frame: Surgery to 6 weeks postop (+/- 2 weeks) ]Numerical patient reported pain scales.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711592
|Contact: Alexandra N Sympson, BAfirstname.lastname@example.org|
|Contact: Pam Plummer, MSNemail@example.com|
|United States, Ohio|
|Good Samaritan Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Alex Sympson, BA 513-862-1904 firstname.lastname@example.org|
|Contact: Pam Plummer, MSN 513-862-6918 email@example.com|
|Principal Investigator: Mark A Snyder, MD|
|Principal Investigator:||Mark Snyder, MD||TriHealth Inc.|