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NCT05367609NARecruiting

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

Senthil Sadhasivam

Start Date

9/20/2022

Completion Date

10/30/2027

Summary

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

Eligibility Criteria

Age Range: 10 years to 21 years

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

Interventions

DIAGNOSTIC_TEST

Preoperative Genotyping

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Conditions

PPAPSpine Fusion

Locations

University of California

San Francisco, California 38456

United States

Children's Orthopaedic and Scoliosis Surgery Associates, LLP

St. Petersburg, Florida 33701

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

Riley Children's Hospital

Indianapolis, Indiana 46202

United States

UPMC Children's Hospital

Pittsburgh, Pennsylvania 15224

United States