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Recruiting NCT05367609

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

No phase Interventional PPAP Spine Fusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative Genotyping.
Who it may be relevant to
Registry conditions: PPAP, Spine Fusion. Basic parameters: 10 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia.

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 PI 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 PI 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

Interventions

  • Diagnostic test Preoperative Genotyping
    Genotype based risk prediction and personalized pain management

Primary outcome measures

  • 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]
  • Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodone [Time frame: At home up to 1 year post-surgery]
  • Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone [Time frame: Immediately post-surgery]
  • Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone [Time frame: At home up to 1 year post-surgery]
Secondary outcome measures (1)
  • Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic [Time frame: Pre-operative to post-operative day 2]

Eligibility criteria

Inclusion criteria

  • Children ages 10 to 21
  • ASA physical status 1 to 3
  • Undergoing Posterior-Lateral Spinal Fusion
  • Receives in-patient opioids
  • Prescribed opioids at discharge

Exclusion criteria

  • Serious illness
  • Preoperative severe pain
  • Preoperative opioid use or misuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • University of California — San Francisco
  • Children's Orthopaedic and Scoliosis Surgery Associates, LLP — St. Petersburg
  • Johns Hopkins All Children's Hospital — St. Petersburg
  • Riley Children's Hospital — Indianapolis
  • UPMC Children's Hospital — Pittsburgh

Identifiers

NCT: NCT05367609 · STUDY21090075 · TR003719

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗