Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Senthil Sadhasivam
Study ID
NCT05380531
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Preoperative Genotyping — DIAGNOSTIC_TEST
    Genotype based risk prediction and personalized pain management

Study Details

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

Key Dates

Start date
Dec 5, 2022
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
700 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Riley Children's Hospital- Clinics / Labor and Delivery UnitIndianapolisIndiana46202
David M. Haas, MD
[email protected]
317-880-3960
Jill Wallace, CIP
[email protected]
317-278-2311
David M. Haas, MD (PRINCIPAL_INVESTIGATOR)
Washington University HospitalSt LouisMissouri63110
Arvind Palanisamy, MD
[email protected]
314-362-2330
Carissa Minder
[email protected]
314-747-6845
University of PittsburghPittsburghPennsylvania15260
Amy Monroe, MPH
[email protected]
412-623-6382
UPMC Magee Women's HospitalPittsburghPennsylvania15213
Katherine Grace Lim, MD
[email protected]
412-641-4260

Find similar trials in Indianapolis, IN

By condition
Substance use disorder
By specialty
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By research site
Riley Children's Hospital- Clinics / Labor and Delivery Unit· Indianapolis, INWashington University Hospital· St Louis, MOUniversity of Pittsburgh· Pittsburgh, PAUPMC Magee Women's Hospital· Pittsburgh, PA

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