Trial Outcomes & Findings for Pharmacogenetic-guided Choice of Post-surgery Analgesics (NCT NCT05548660)
NCT ID: NCT05548660
Last Updated: 2026-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
0-30 days
Results posted on
2026-04-01
Participant Flow
261 screen failures, 42 missed, 44 declined, and 4 other
Participant milestones
| Measure |
PGx-guided
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Overall Study
PGx Test Completed
|
53
|
57
|
|
Overall Study
STARTED
|
54
|
58
|
|
Overall Study
Met Inclusion Criteria
|
54
|
57
|
|
Overall Study
Eligible Surgery Completed Within Health System
|
48
|
53
|
|
Overall Study
COMPLETED
|
48
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
PGx-guided
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
6
|
4
|
Baseline Characteristics
Pharmacogenetic-guided Choice of Post-surgery Analgesics
Baseline characteristics by cohort
| Measure |
PGx-guided
n=54 Participants
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
n=58 Participants
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
47 Participants
n=5 Participants
|
89 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
58 Participants
n=5 Participants
|
112 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
58 Participants
n=5 Participants
|
111 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
57 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=5 Participants
|
50 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
58 participants
n=5 Participants
|
112 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 0-30 daysNumber 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.
Outcome measures
| Measure |
PGx-guided
n=48 Participants
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
n=53 Participants
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient
|
35 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: For the PGx arm, the outcome was based on the population with results prior to surgery. For the usual care arm, it was based on the whole population.
Number of Participants Prescribed Opioids or NSAIDS According to Genotyping
Outcome measures
| Measure |
PGx-guided
n=35 Participants
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
n=53 Participants
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Fidelity to Genotype-guided Pharmacotherapy Recommendations
NSAID Recommendations
|
32 Participants
|
31 Participants
|
|
Fidelity to Genotype-guided Pharmacotherapy Recommendations
Opioid Recommendations
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Eligible participants with at least one survey response. (Please note that outcomes 2 and 3 are unrelated. Outcome 2 relates to if physicians complied with recommended pharmacogenomics pain relief medications. Outcome 3 is for all participants with pain scores unrelated to the PGx results.)
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
Outcome measures
| Measure |
PGx-guided
n=40 Participants
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
n=43 Participants
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Acute Pain - Self-reported Numeric Pain Score
Day 3 Pain Score among participants prescribed NSAIDs
|
4.9 score on a scale
Interval 3.7 to 6.0
|
4.6 score on a scale
Interval 3.3 to 5.88
|
|
Acute Pain - Self-reported Numeric Pain Score
Day 3 Pain Score among participants prescribed opioids
|
5.1 score on a scale
Interval 3.8 to 6.4
|
4.9 score on a scale
Interval 3.5 to 6.17
|
|
Acute Pain - Self-reported Numeric Pain Score
Day 7 Pain Score among participants prescribed NSAIDs
|
3.7 score on a scale
Interval 2.5 to 4.83
|
3.8 score on a scale
Interval 2.6 to 4.95
|
|
Acute Pain - Self-reported Numeric Pain Score
Day 7 Pain Score among participants prescribed opioids
|
3.8 score on a scale
Interval 2.5 to 5.1
|
3.7 score on a scale
Interval 2.5 to 4.99
|
|
Acute Pain - Self-reported Numeric Pain Score
Day 14 Pain Score among participants prescribed NSAIDs
|
2.0 score on a scale
Interval 0.8 to 3.11
|
3.0 score on a scale
Interval 1.8 to 4.29
|
|
Acute Pain - Self-reported Numeric Pain Score
Day 14 Pain Score among participants prescribed opioids
|
2.2 score on a scale
Interval 1.0 to 3.48
|
2.9 score on a scale
Interval 1.6 to 4.17
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Not all participants answered all three surveys. Overall participants analyzed notes those who answered at least one.
Difference in total MME consumption in variant carriers in PGx-guided group vs. control group
Outcome measures
| Measure |
PGx-guided
n=40 Participants
Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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.
Pharmacist 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
|
Usual Care
n=43 Participants
Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)
Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
Pharmacist 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
|
|---|---|---|
|
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Postoperative Day 3
|
58.8 morphine milligram equivalents
Interval 21.5 to 96.0
|
67.8 morphine milligram equivalents
Interval 33.1 to 103.0
|
|
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Postoperative Day 7
|
37.8 morphine milligram equivalents
Interval -0.1 to 75.73
|
41.9 morphine milligram equivalents
Interval 7.6 to 76.29
|
|
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Postoperative Day 14
|
32.3 morphine milligram equivalents
Interval -5.9 to 70.42
|
36.3 morphine milligram equivalents
Interval 0.6 to 72.08
|
Adverse Events
PGx-guided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place