Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Overview
- Phase
- Not Applicable
- Intervention
- Preoperative Genotyping
- Conditions
- Cesarean Section Complications
- Sponsor
- Senthil Sadhasivam
- Enrollment
- 700
- Locations
- 5
- Primary Endpoint
- Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
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
Detailed 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.
Investigators
Senthil Sadhasivam
Professor
University of Pittsburgh
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
- •Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
- •Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
- •Preoperative severe pain and opioid use/misuse, allergy to oxycodone
- •Allergy to oxycodone
- •Significant neurological disorders, liver and renal diseases
Arms & Interventions
Mother undergoing planned Cesarean section
Mother subject will have genotyping blood draw performed at the time of controlled delivery (CD). Blood samples and breast milk samples will also be taken during the oxycodone dosing schedule.
Intervention: Preoperative Genotyping
Infant
Infant subject will have genotyping blood draw performed only at the time of controlled delivery (CD)
Intervention: Preoperative Genotyping
Outcomes
Primary Outcomes
Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
Time Frame: At home up to 1 year post-surgery
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
Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone
Time Frame: At home up to 1 year post-surgery
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.
Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
Time Frame: Immediately post-surgery during hospital stay
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
Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone
Time Frame: Immediately post-surgery during hospital stay
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.
Secondary Outcomes
- Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in patients to see if specific variants correlate with a need for lower or higher doses of analgesic.(Pre-operative to post-operative day 2)