Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

NCT05380531 | Recruiting DMC

• 2 other identifiers: STUDY211001671U01TR003719-01A1
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 4

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

Conditions

Cesarean Section Complications; Opioid Use

Keywords

Opioid Exposure

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  At home up to 1 year post-surgery

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery

  Post-operative up to 1-year

• Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery

  Post-operative up to 1-year

• Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery

  Post-operative up to 1-year

Study Arms (2)

Mother undergoing planned Cesarean section

EXPERIMENTAL

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.

Diagnostic Test: Preoperative Genotyping

Infant

EXPERIMENTAL

Infant subject will have genotyping blood draw performed only at the time of controlled delivery (CD)

Diagnostic Test: Preoperative Genotyping

Interventions

Preoperative Genotyping DIAGNOSTIC_TEST

Genotype based risk prediction and personalized pain management

Infant; Mother undergoing planned Cesarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Senthil Sadhasivam: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (4)

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

Indianapolis, Indiana, 46202, United States

RECRUITING

Washington University Hospital

St Louis, Missouri, 63110, United States

RECRUITING

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Study Officials

• Senthilkumar Sadhasivam, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senthilkumar Sadhasivam, MD, MPH

CONTACT

4126472994; sadhasivams@upmc.edu

Dayana Alsamsam, MPH

CONTACT

alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Interventional study with mother undergoing elective c-section and the infant

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 19, 2022
• Study Start: December 5, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)