Pharmacogenetic-guided Choice of Post-surgery Analgesics
NCT ID: NCT05548660
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2022-10-13
2025-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
2. Pregnancy
3. Breastfeeding
4. Treating physician does not want subject to participate
18 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Sony Tuteja
Research Assistant Professor of Medicine, Division of Translational Medicine and Human Genetics; Assistant Director, Pharmacogenomics Penn Center for Precision Medicine
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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851447
Identifier Type: -
Identifier Source: org_study_id
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