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The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.
Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenomic (PGx) guided | Experimental | Subjects will have Pharmacogenomic (PGx) testing preoperatively. The pharmacists will review results and make recommendations to the anesthesia and orthopedic teams for perioperative anesthesia and analgesia. The teams will use this information to drive clinical decisions as they see fit. |
|
| Control | Active Comparator | Subjects will undergo Pharmacogenomic (PGx) preoperatively but the results will be sealed until completion of treatment and clinicians will not have access to this information. These patients will undergo standard treatment dosing and medication selection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic (PGx) | Other | Administer a pharmacogenomics test (buccal swab) during the pre-operative setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Benefit of Analgesic Score (OBAS) | The overall benefit of analgesia score (OBAS) is a daily multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events (ORAEs), and patient satisfaction. It is a seven-item scale, with items ranging from( 0 = not at all) to(4 = very much). To calculate the Total OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Low score indicates high benefit. | baseline, 48 hours following PACU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in prescription pattern for postoperative pain control. | Overall benefit of change in opioid prescription | baseline, 48 hours following PACU discharge |
| Change in Opioid requirements | Opioid doses will be recorded and converted into morphine equivalents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly B Kraus | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37594401 | Derived | Kraus MB, Bingham JS, Kekic A, Erickson C, Grilli CB, Seamans DP, Upjohn DP, Hentz JG, Clarke HD, Spangehl MJ. Does Preoperative Pharmacogenomic Testing of Patients Undergoing TKA Improve Postoperative Pain? A Randomized Trial. Clin Orthop Relat Res. 2024 Feb 1;482(2):291-300. doi: 10.1097/CORR.0000000000002767. Epub 2023 Aug 18. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
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Participants will not be aware of which arm of the study they are enrolled.
| Review results | Other | Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions. |
|
| baseline, 48 hours following PACU discharge |
| Changes in opioid use perioperatively based on pharmacogenomic testing | Opioid doses will be recorded and converted into morphine equivalents. | baseline, 48 hours following PACU discharge |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |