Acute Pain, Post Operative Pain
Conditions
Brief summary
Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects or therapeutic failure from analgesics. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing surgeons with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide analgesic choice and improve patient outcomes. This is a prospective, two-arm randomized implementation study. Eligible participants will be randomly assigned to receive genotype-guided analgesic selection (intervention arm) or usual care (control arm). Both cohorts will undergo pharmacogenetic testing at the time of consenting. The investigators will primarily measure the feasibility of using this test to guide analgesic selection.
Interventions
Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
OTHERPharmacist note with genotype-guided analgesic recommendations
CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone.
OTHERPharmacist detailed note with genotype-guided recommendations per CPIC guidelines
Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide informed consent 2. Assigned female at birth and aged 18 years or older at the time of study initiation 3. Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery 4. Willing to provide a buccal swab for PGx testing and comply with all study-related procedures
Exclusion criteria
1. Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid 2. Pregnancy 3. Breastfeeding 4. Treating physician does not want subject to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient | 0-30 days | Number of Participants with PGx Test Results and Pharmacist Consult Notes Returned Per Protocol. Before surgery for the PGx-guided arm, and after surgery for the Usual care arm. |
| Fidelity to Genotype-guided Pharmacotherapy Recommendations | 14 days | Number of Participants Prescribed Opioids or NSAIDS According to Genotyping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Pain - Self-reported Numeric Pain Score | 14 days | Mean patient self-reported numeric pain scores (scale: 0-10, 0 = no pain; 10= worst pain imaginable) assessed on POD 0, 3, 7, 14 in the PGx-guided group vs. the control group |
| Total Opioid Consumption in Morphine Milligram Equivalents (MME) | 14 days | Difference in total MME consumption in variant carriers in PGx-guided group vs. control group |
Countries
United States
Participant flow
Pre-assignment details
261 screen failures, 42 missed, 44 declined, and 4 other
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 53 |
| other Total, other adverse events | 0 / 48 | 0 / 53 |
| serious Total, serious adverse events | 0 / 48 | 0 / 53 |
Outcome results
None listed