Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
NCT ID: NCT05367609
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-09-20
2026-09-30
Brief Summary
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Detailed Description
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Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)
1. Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The investigators postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
2. Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids
The investigators hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Preoperative Genotyping
Genotype based risk prediction and personalized pain management
Interventions
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Preoperative Genotyping
Genotype based risk prediction and personalized pain management
Eligibility Criteria
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Inclusion Criteria
* ASA physical status 1 to 3
* Undergoing Posterior-Lateral Spinal Fusion
* Receives in-patient opioids
* Prescribed opioids at discharge
Exclusion Criteria
* Preoperative severe pain
* Preoperative opioid use or misuse
10 Years
21 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Senthil Sadhasivam
OTHER
Responsible Party
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Senthil Sadhasivam
Professor
Principal Investigators
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Senthilkumar Sadhasivam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of California
San Francisco, California, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TR003719
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY21090075
Identifier Type: -
Identifier Source: org_study_id
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