Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Senthil Sadhasivam700 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Cesarean Section Complications Opioid Use

Interventions

Preoperative GenotypingDIAGNOSTIC_TEST

Genotype based risk prediction and personalized pain management

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Riley Children's Hospital- Clinics / Labor and Delivery Unit

Indianapolis, Indiana, United States

RECRUITING

Washington University Hospital

St Louis, Missouri, United States

RECRUITING

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)

The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital

Time frame: Immediately post-surgery during hospital stay

Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)

The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience RD and PONV in the post-surgical period at home up to 1-year

Time frame: At home up to 1 year post-surgery

Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone

The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be measured using the Numerical Rating Scale (NRS), which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.

Time frame: Immediately post-surgery during hospital stay

Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone

The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be measured using the Numerical Rating Scale (NRS), which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.

Time frame: At home up to 1 year post-surgery

Secondary Outcomes

Central Contacts

Senthilkumar Sadhasivam, MD, MPH

CONTACT

4126472994 sadhasivams@upmc.edu

Dayana Alsamsam, MPH

CONTACT

alsamsamd@upmc.edu

Data from ClinicalTrials.gov

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