Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
NCT ID: NCT05380531
Last Updated: 2025-09-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
600 participants
INTERVENTIONAL
2022-12-05
2026-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Shared Decision Making for Prescription Opioids After Cesarean Delivery
NCT02770612
Chronic Pain Dynamic Psychophysical Tests and Genetic Screening
NCT02373696
Opioid Prescription After Cesarean Trial
NCT04296396
Precision Opioid Care After Cesarean Delivery (PRECISE-CD)
NCT05280743
Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes
NCT05333731
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
SPECIFIC AIMS: The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in
Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, Clinical Pharmacogenetics Implementation (CPIC) guidelines, precision dosing, clinical safety, and personalizing analgesia
Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following Cesarean Section The investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants will explain clinical and pharmacokinetic variations of oxycodone, and PPAP implementation will reduce adverse effects in mothers and infants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mother undergoing planned Cesarean section
Mother subject will have genotyping blood draw performed at the time of controlled delivery (CD). Blood samples and breast milk samples will also be taken during the oxycodone dosing schedule.
Preoperative Genotyping
Genotype based risk prediction and personalized pain management
Infant
Infant subject will have genotyping blood draw performed only at the time of controlled delivery (CD)
Preoperative Genotyping
Genotype based risk prediction and personalized pain management
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Preoperative Genotyping
Genotype based risk prediction and personalized pain management
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone
4. Allergy to oxycodone
5. Significant neurological disorders, liver and renal diseases
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Advancing Translational Sciences (NCATS)
NIH
Senthil Sadhasivam
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Senthil Sadhasivam
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Senthilkumar Sadhasivam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY21100167
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.