NCT05380531 Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
| NCT ID | NCT05380531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Senthil Sadhasivam |
| Condition | Cesarean Section Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2022-12-05 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2022-12-05 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this collaborative CTSA (Clinical and Translational Science Award) 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 breastfeeding mothers and their infants
Eligibility 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
Contact & Investigator
Senthilkumar Sadhasivam, MD, MPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05380531 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cesarean Section Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05380531 currently recruiting?
Yes, NCT05380531 is actively recruiting participants. Contact the research team at sadhasivams@upmc.edu for enrollment information.
Where is the NCT05380531 trial being conducted?
This trial is being conducted at Indianapolis, United States, St Louis, United States, Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT05380531 clinical trial?
NCT05380531 is sponsored by Senthil Sadhasivam. The principal investigator is Senthilkumar Sadhasivam, MD, MPH at University of Pittsburgh. The trial plans to enroll 700 participants.