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Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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 adverse outcomes of perioperative opioids and precision dosing in nursing mothers and infants (Aim 2).

SPECIFIC AIMS: The purpose of this collaborative CTSA 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

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, Clinical Pharmacogenetics Implementation (CPIC) guidelines, precision dosing, clinical safety, and personalizing analgesia

Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following Cesarean Section The investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants will explain clinical and pharmacokinetic variations of oxycodone, and PPAP implementation will reduce adverse effects in mothers and infants.

Eligibility

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

Study details
    Cesarean Section Complications
    Opioid Use

NCT05380531

Senthil Sadhasivam

27 January 2024

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