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| ID | Type | Description | Link |
|---|---|---|---|
| CORNET Award | Other Grant/Funding Number | The University of Tennessee Graduate School of Medicine |
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The main questions this study aims to answer are:
Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?
Participants will:
Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.
Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard post-operative pain management (control) | Active Comparator | Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain. |
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| Pharmacogenomics (PGx) guided treatment (hydromorphone) | Experimental | Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGx guided personalized post-operative pain management | Other | Patients in the intervention group will receive post operative opioid therapy based on their pharmacogenomic results. Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Patients who are intermediate or normal CYP2D6 metabolizers with moderate or severe pain will receive oxycodone 5mg or oxycodone 10mg every 4 hours as needed respectively similar to the treatment offered to the control subjects. Normal or intermediate CYP2D6 metabolizers who are concomitantly taking a drug which is a strong CYP2D6 inducer will be treated as if they are in the rapid metabolizer group, and normal or intermediate patients that are concomitantly taking a drug which is a strong CYP2D6 inhibitor will be treated as if they were a poor metabolizer. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Post-Operative Opioid Use | To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Surgical Pain | To determine if PGx guided medication improves post-operative pain scores compared to similar patients who are given the standard current post operative opiate treatment. The scores are being rated using the Face, Legs, Activity, Cry and Consolability scale ranging from a minimum value of 0 to a maximum value of 10. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Related Adverse Events | To determine if PGx guided medication reduces total opioid related adverse events compared to standard post operative opiate therapy. | 90 days |
Inclusion Criteria:
1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tennessee Graduate School of Medicine | Knoxville | Tennessee | 37920 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Standard of Care (oxycodone) versus intervention group (hydromorphone)
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| Oxycodone | Drug | oxycodone |
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| Hydromorphone | Drug | hydromorphone |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |