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Recruiting NCT05380531

Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Trial Parameters

Condition Cesarean Section Complications
Sponsor Senthil Sadhasivam
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-12-05
Completion 2026-04-30
Interventions
Preoperative Genotyping

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

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