Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Last updated: September 15, 2025
Sponsor: Senthil Sadhasivam
Overall Status: Active - Recruiting

Phase

N/A

Condition

Drug Use

Treatment

Preoperative Genotyping

Clinical Study ID

NCT05380531
STUDY21100167
1U01TR003719-01A1
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

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

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 clinicalnotes

  3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone

  4. Allergy to oxycodone

  5. Significant neurological disorders, liver and renal diseases

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Preoperative Genotyping
Phase:
Study Start date:
December 05, 2022
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • UPMC Magee Women's Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • UPMC Magee Women's Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15260
    United States

    Active - Recruiting

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