Personalized pain management for cesarean sections
Official title: Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Run by University of Pittsburgh · NCT05380531 · Data updated 2026-11-12
This study is testing a new way to manage pain for breastfeeding mothers after cesarean sections to see if it can reduce side effects from opioids and improve recovery for both moms and their babies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 700 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 4 sites (Indianapolis, Indiana and 3 other locations) |
| Status | Recruiting |
| Started | December 5, 2022 |
| Main results expected | April 30, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT05380531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women over 18 years old, of any race, who are undergoing elective cesarean sections and are willing to receive in-patient opioids.
✕Probably not a fit
Patients with uncontrolled diabetes, hypertension, a history of opioid misuse, severe preoperative pain, or allergies to oxycodone may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop a personalized perioperative analgesia platform (PPAP) to enhance pain management and minimize adverse effects of opioids in breastfeeding mothers undergoing cesarean sections. The approach involves creating a framework that integrates genomics with opioid metabolism and precision dosing to tailor analgesia for individual patients. The study will evaluate the effectiveness of this platform in reducing complications for both mothers and their infants post-surgery.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and reduce opioid-related complications for mothers and their newborns.
How similar studies have gone: Other studies have shown promise in personalized pain management approaches, but this specific application of a precision analgesia platform is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult women (\>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids. Exclusion Criteria: 1. Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic) 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
Where it's running
-
Riley Children's Hospital- Clinics / Labor and Delivery Unit
Indianapolis, Indiana, United States Recruiting -
Washington University Hospital
St Louis, Missouri, United States Recruiting -
University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting -
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: Senthilkumar Sadhasivam, MD, MPH — University of Pittsburgh
- Study coordinator: Senthilkumar Sadhasivam, MD, MPH
- Email: sadhasivams@upmc.edu
- Phone: 4126472994
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.