Personalized pain management for cesarean sections
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 4 sites (Indianapolis, Indiana and 3 other locations) |
| Trial ID | NCT05380531 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in personalized pain management approaches, but this specific application of a precision analgesia platform is relatively novel.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana and 3 other locations
- Riley Children's Hospital- Clinics / Labor and Delivery Unit — Indianapolis, Indiana, United States (Recruiting)
- Washington University Hospital — St Louis, Missouri, United States (Recruiting)
- UPMC Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Senthilkumar Sadhasivam, MD, MPH — University of Pittsburgh
- Study coordinator: Senthilkumar Sadhasivam, MD, MPH
- Email: sadhasivams@upmc.edu
- Phone: 4126472994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.