Acute PainPRECISENCT05548660
Pharmacogenetic-guided Choice of Post-surgery Analgesics
A study testing Pharmacogenetic testing, Pharmacist note with genotype-guided analgesic recommendations and Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines in people with Acute Pain and Post Operative Pain, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Pain, Post Operative Pain
- What is being tested?
- Pharmacogenetic testing, Pharmacist note with genotype-guided analgesic recommendations and Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent
- Assigned female at birth and aged 18 years or older at the time of study initiation
- Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
- Willing to provide a buccal swab for PGx testing and comply with all study-related procedures
Who cannot join
- Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
- Pregnancy
- Breastfeeding
- Treating physician does not want subject to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Acute Pain, Post Operative Pain
- Being tested
- Pharmacogenetic testing, Pharmacist note with genotype-guided analgesic recommendations, Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingOther
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 recommendationsOther
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 guidelinesOther
Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling
| Study group | Role | What they receive |
|---|---|---|
| PGx-guided | Experimental | 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. Receives: Other: Pharmacogenetic testing; Other: Pharmacist note with genotype-guided analgesic recommendations; Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines |
| Usual care | Other | 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) Receives: Other: Pharmacogenetic testing; Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient
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.
Measured: 0-30 days
Fidelity to Genotype-guided Pharmacotherapy Recommendations
Number of Participants Prescribed Opioids or NSAIDS According to Genotyping
Measured: 14 days
Secondary outcomes (2)
Acute Pain - Self-reported Numeric Pain Score
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
Measured: 14 days
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Difference in total MME consumption in variant carriers in PGx-guided group vs. control group
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start13 Oct 2022
- Primary completion20 Oct 2023
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sony Tuteja, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548660
- Sponsor's protocol ID
- 851447
- Acronym
- PRECISE
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2022
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic-guided Choice of Post-surgery Analgesics
- ClinicalTrials.gov ID
- NCT05548660
- Acronym / sponsor ID
- PRECISE / 851447
- Conditions
- Acute Pain, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia
| Arm | Type | Receives |
|---|---|---|
| PGx-guided | Experimental | Other: Pharmacogenetic testing, Other: Pharmacist note with genotype-guided analgesic recommendations, Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelinesPharmacogenetic 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. |
| Usual care | Other | Other: Pharmacogenetic testing, Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelinesPharmacogenetic 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide informed consent
- Assigned female at birth and aged 18 years or older at the time of study initiation
- Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
- Willing to provide a buccal swab for PGx testing and comply with all study-related procedures
Key exclusion criteria (4 listed)
- Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
- Pregnancy
- Breastfeeding
- Treating physician does not want subject to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testingGenetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. | Other | PGx-guided, Usual care |
| Pharmacist note with genotype-guided analgesic recommendationsCYP2C9 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. | Other | PGx-guided |
| Pharmacist detailed note with genotype-guided recommendations per CPIC guidelinesGenotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling | Other | PGx-guided, Usual care |
Primary outcome
Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient
Time frame: 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
Time frame: 14 days
Number of Participants Prescribed Opioids or NSAIDS According to Genotyping
2 secondary outcomes
Acute Pain - Self-reported Numeric Pain Score
Time frame: 14 days
Total Opioid Consumption in Morphine Milligram Equivalents (MME)
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic testing, Pharmacist note with genotype-guided analgesic recommendations and Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines in people with Acute Pain and Post Operative Pain, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient (time frame: 0-30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.