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

NCT05367609 | Recruiting DMC

• 2 other identifiers: STUDY21090075TR003719
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

PPAP; Spine Fusion

Keywords

PPAP; Pediatric; Spine Fusion Surgery

Outcome Measures

Primary Outcomes (4)

• Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)

  The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital

  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

  The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the post-surgical period at home up to 1-year

  At home up to 1 year post-surgery

• Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone

  The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.

  Immediately post-surgery

• Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone

  The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.

  At home up to 1 year post-surgery

Secondary Outcomes (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

  Pre-operative to post-operative day 2

Other Outcomes (2)

• Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery

  Post-operative up to 1-year

• Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery

  Post-operative up to 1-year

Study Arms (1)

Children undergoing Spine Fusion Surgery

OTHER

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.

Diagnostic Test: Preoperative Genotyping

Interventions

Preoperative Genotyping DIAGNOSTIC_TEST

Genotype based risk prediction and personalized pain management

Children undergoing Spine Fusion Surgery

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Senthil Sadhasivam: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (5)

University of California

San Francisco, California, 38456, United States

RECRUITING

Children's Orthopaedic and Scoliosis Surgery Associates, LLP

St. Petersburg, Florida, 33701, United States

NOT YET RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

NOT YET RECRUITING

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Study Officials

• Senthilkumar Sadhasivam, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senthilkumar Sadhasivam, MD, MPH

CONTACT

4126472994; sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

CONTACT

alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: PK sampling and genetic testing will determine the type of analgesia medication treatment the patient receives

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 10, 2022
• Study Start: September 20, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)