Actively Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Led by Senthil Sadhasivam · Updated on 2026-04-14
700
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Senthil Sadhasivam
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing a personalized perioperative precision analgesia platform (PPAP) to improve pain control and reduce serious short- and long-term side effects from opioid use in breastfeeding mothers and their infants after Cesarean section. This collaborative study focuses on linking genetic factors to opioid metabolism and personalizing pain management to enhance safety and effectiveness. The study involves genotyping mothers and infants around the time of Cesarean delivery to assess genetic variants such as CYP2D6 that influence oxycodone response. Mothers will have blood and breast milk samples collected during oxycodone dosing. The research evaluates how these genetic profiles affect opioid dosing, pain relief, and opioid-related adverse effects, including respiratory depression and nausea. Participants will be monitored during their hospital stay and followed at home for up to one year after surgery. The study measures immediate and longer-term opioid side effects, pain relief adequacy, and the impact of genetic variants on dosing needs. Blood and milk samples, along with clinical assessments, are used to track outcomes and safety throughout the study period.
CONDITIONS
Brief Title
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women over 18 years old
- Any race
- American Society of Anesthesiologists Classification (ASA) physical status 1 to 3
- Undergoing elective Cesarean section
- Willing to receive inpatient opioid pain medication
You will not qualify if you...
- Uncontrolled diabetes (gestational or pre-existing)
- Uncontrolled hypertension including pre-eclampsia, eclampsia, or chronic hypertension
- History of opioid misuse before or during pregnancy
- Severe preoperative pain and opioid use or misuse
- Allergy to oxycodone
- Significant neurological disorders
- Liver or kidney disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From pre-operative period through post-operative day 2
Participants undergo elective Cesarean section with genotyping blood draws performed at the time of delivery. Mothers receive personalized opioid pain management based on genotyping, including blood and breast milk sampling during oxycodone dosing.
1 hospital stay including controlled delivery and pain management visits
Duration - Up to 1 year post-surgery
Participants and their infants are monitored at home for up to 1 year to assess opioid-related adverse effects and pain relief outcomes.
Periodic at-home assessments during the year
Trial Site Locations
Total: 4 locations
1
Riley Children's Hospital- Clinics / Labor and Delivery Unit
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Washington University Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
3
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
Research Team
S
Senthilkumar Sadhasivam, MD, MPH
D
Dayana Alsamsam, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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