Perioperative/Postoperative Complications
Conditions
Keywords
pharmacogenomics, preoperative evaluation, perioperative opioid use
Brief summary
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
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.
Interventions
OTHERPharmacogenomic (PGx)
Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
OTHERReview results
Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Participants will not be aware of which arm of the study they are enrolled.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Benefit of Analgesic Score (OBAS) | baseline, 48 hours following PACU discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in prescription pattern for postoperative pain control. | baseline, 48 hours following PACU discharge | Overall benefit of change in opioid prescription |
| Change in Opioid requirements | baseline, 48 hours following PACU discharge | Opioid doses will be recorded and converted into morphine equivalents. |
| Changes in opioid use perioperatively based on pharmacogenomic testing | baseline, 48 hours following PACU discharge | Opioid doses will be recorded and converted into morphine equivalents. |
Countries
United States
Outcome results
None listed