Recruiting

Perioperative Precision Analgesia

Sponsor:

Senthil Sadhasivam

Code:

NCT05367609

Conditions

PPAP

Spine Fusion

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Interventions

Preoperative Genotyping

Study Details

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

Study ID

NCT05367609

Start date

Sep 20, 2022

Status verified date

Sep, 2025

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Preoperative Genotyping

Genotype based risk prediction and personalized pain management

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Senthilkumar Sadhasivam, MD, MPH

4126472994sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

alsamsamd@upmc.edu

Locations

University of California

Recruiting

San Francisco, California, United States, 38456

Contacts

Ridhima Jain

Ridhma.jain@ucsf.edu

Principal Investigator:

Anshuman Sharma

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Senthil Packiasabhapathy, MD

sepack@iu.edu

Principal Investigator:

Senthil Packiasabhapathy, MD

UPMC Children's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Senthilkumar Sadhasivam, MD, MPH

412-647-2994sadhasivams@upmc.edu

More Information

Sponsor

Senthil Sadhasivam

Last update posted

Apr 13, 2026

Last verified

Sep, 2025

Keywords

  • PPAP
  • Pediatric
  • Spine Fusion Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Senthil Sadhasivam on 2026-04-13.