Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Conditions
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Perioperative/Postoperative Complications

Intervention / Treatment
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* Other: Pharmacogenomic (PGx)
* Other: Review results


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing primary total knee arthroplasty Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures. Exclusion Criteria: Patients with a current diagnosis of chronic pain Patients requiring narcotics for greater than one week prior to surgery Patients with chronic kidney disease with a pre-op creatinine greater than 1.5 Patient preference or need for spinal anesthesia rather than general anesthesia Patient planned for robotic surgical approach

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacogenomic (PGx) guided<br>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. | Other: Pharmacogenomic (PGx)<br>* Administer a pharmacogenomics test (buccal swab) during the pre-operative setting<br>Other: Review results<br>* Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.<br>|
| Active Comparator: Control<br>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. | Other: Pharmacogenomic (PGx)<br>* Administer a pharmacogenomics test (buccal swab) during the pre-operative setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacogenomics, preoperative evaluation, perioperative opioid use