Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
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
| Condition(s) | Cesarean Section Complications, Opioid Use |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Senthil Sadhasivam |
| Locations | Indianapolis, Indiana, United States; St Louis, Missouri, United States; Pittsburgh, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States |
| Start date | 2022-12-05 |
| NCT ID | NCT05380531 |
| Official listing | https://clinicaltrials.gov/study/NCT05380531 |