Recruiting

PPAP

Sponsor:

Senthil Sadhasivam

Code:

NCT05380531

Conditions

Cesarean Section Complications

Opioid Use

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Preoperative Genotyping

Study Details

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

Study ID

NCT05380531

Start date

Dec 5, 2022

Status verified date

Sep, 2025

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

700 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: Infant

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

Interventions

Preoperative Genotyping

Genotype based risk prediction and personalized pain management

Primary outcome measure

  • 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 ]
  • 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 ]
  • Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone [ Time Frame: Immediately post-surgery during hospital stay ]
  • Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone [ Time Frame: At home up to 1 year post-surgery ]

Central Contacts and Locations

Central contacts

Senthilkumar Sadhasivam, MD, MPH

4126472994sadhasivams@upmc.edu

Dayana Alsamsam, MPH

alsamsamd@upmc.edu

Locations

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

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

David M. Haas, MD

317-880-3960dahaas@iu.edu

Jill Wallace, CIP

317-278-2311jilawall@iu.edu

Principal Investigator:

David M. Haas, MD

Washington University Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Arvind Palanisamy, MD

314-362-2330arvind.palanisamy@wustl.edu

Carissa Minder

314-747-6845Carissa.minder@wustl.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Amy Monroe, MPH

412-623-6382monroeal@upmc.edu

More Information

Sponsor

Senthil Sadhasivam

Last update posted

Apr 14, 2026

Last verified

Sep, 2025

Keywords

  • Opioid Exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Senthil Sadhasivam on 2026-04-14.