Status:
RECRUITING
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Lead Sponsor:
Senthil Sadhasivam
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Cesarean Section Complications
Opioid Use
Eligibility:
FEMALE
18+ years
Phase:
NA
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 red...
Detailed Description
The approach includes 1) development and implementation of an innovative PPAP infrastructure at participating CTSA hubs (Aim 1) and 2) to improve analgesia and reduce serious immediate and long-term a...
Eligibility Criteria
Inclusion
- 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
- Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
- Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
- Preoperative severe pain and opioid use/misuse, allergy to oxycodone
- Allergy to oxycodone
- Significant neurological disorders, liver and renal diseases
Key Trial Info
Start Date :
December 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05380531
Start Date
December 5 2022
End Date
October 30 2026
Last Update
September 19 2025
Active Locations (2)
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1
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260