Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

Part of paid clinical trials in San Francisco, California.

Sponsor
Senthil Sadhasivam
Study ID
NCT05367609
Status
Recruiting
Apply to this trial

Conditions

  • PPAP
  • Spine Fusion

Eligibility Criteria

Sex
ALL
Age
10 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 children undergoing painful surgery.

Key Dates

Start date
Sep 20, 2022
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Children undergoing Spine Fusion Surgery
    This arm will include approximately 300 children undergoing spine fusion surgery 1. Pharmacokinetic (PK): collection of 10-13 serial blood samples to determine serum levels of methadone/oxycodone and its metabolites 2. Pharmacogenetic (PG): Preoperative CYP2D6 genotyping (for preferential recruitment of CYP2D6 PMs and UMs). This will be collected in the pre-operative clinic via blood if there are clinical labs needed for standard of care. If no blood is needed in the pre-op clinic, the investigators will collect this via saliva. Postoperative Analgesia Dose and PK Sampling Schedule: Clinical care providers are blinded to CYP2D6/CYP2B6 when prescribing oxycodone/methadone; and genetic analysis of proposed targeted genes. Results of these samples will be used to determine personalized analgesia plan.

Primary Outcome Measure

Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) [ Time Frame: Immediately post-surgery up to 4 days in patient ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia38456
Ridhima Jain
[email protected]
Anshuman Sharma (PRINCIPAL_INVESTIGATOR)
Children's Orthopaedic and Scoliosis Surgery Associates, LLPSt. PetersburgFlorida33701
Ryan E. Fitzgerald, MD
[email protected]
813-506-5511
Priscilla Martinez
[email protected]
813-506-5511
Ryan E. Fitzgerald, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701
Frederick Kuo, MD
[email protected]
410-929-2123
Janelle Maddox-Regis, MS, CIP
[email protected]
443-927-1476
Frederick Kuo, MD (PRINCIPAL_INVESTIGATOR)
Riley Children's HospitalIndianapolisIndiana46202
Senthil Packiasabhapathy, MD
[email protected]
Senthil Packiasabhapathy, MD (PRINCIPAL_INVESTIGATOR)
UPMC Children's HospitalPittsburghPennsylvania15224
Senthilkumar Sadhasivam, MD, MPH
[email protected]
412-647-2994

Find similar trials in San Francisco, CA

By research site
University of California· San Francisco, CAChildren's Orthopaedic and Scoliosis Surgery Associates, LLP· St. Petersburg, FLJohns Hopkins All Children's Hospital· St. Petersburg, FLRiley Children's Hospital· Indianapolis, INUPMC Children's Hospital· Pittsburgh, PA

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