Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section (PPAP C-Section)
D
David Haas, MD
Primary Investigator
Enrolling By Invitation
18 years and older
Female
Phase
N/A
600 participants needed
3 Locations
Brief description of study
The purpose of this collaborative CTSA (Clinical and Translational Science Award) applicationdevelop an innovative perioperative precision analgesia platform (PPAP) to improvegesia and reduce serious immediate and long-term adverse outcomes of perioperativeds in breastfeeding mothers and their infants
Detailed description of study
The approach includes 1) development and implementation of an innovative PPAP infrastructureg CTSA hubs (Aim 1) and 2) to improve analgesia and reduce serious immediated long-term adverse outcomes of perioperative opioids and precision dosing in nursinghers and infants (Aim 2).
SPECIFIC AIMS: The purpose of this collaborative CTSA application is to develop an innovativeve precision analgesia platform (PPAP) to improve analgesia and reduce seriousdiate and long-term adverse outcomes of perioperative opioids in
Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking
genomics to opioid metabolism, Clinical Pharmacogenetics Implementation (CPIC) guidelines,dosing, clinical safety, and personalizing analgesia
Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following CesareanThe investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants willd pharmacokinetic variations of oxycodone, and PPAP implementation willduce adverse effects in mothers and infants.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cesarean Section Complications, Opioid Use
-
Age: 18 Years
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Gender: Female
Inclusion Criteria:
Healthy women, >18years, undergoing Cesarean section that receive in-patient opioids andprescribed opioids at discharge.Exclusion Criteria:1. Health conditions including uncontrolled diabetes (gestational or pre-existing) orhypertension (pre-eclampsia, eclampsia, or chronic)2. Any history of opioid misuse before or during pregnancy-per self-report and clinicalnotes3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone4. Significant neurological disorders, liver and renal diseases
Updated on
01 Aug 2024.
Study ID: STUDY21100167, OBGYN-NCATS-PPAP-SIRB, 17484
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