Actively Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Led by Senthil Sadhasivam · Updated on 2026-04-13
300
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Senthil Sadhasivam
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop a personalized perioperative precision analgesia platform (PPAP) to improve pain management and reduce serious immediate and long-term adverse effects of opioids in children undergoing painful surgery, specifically posterior spinal fusion. The study explores genetic factors linked to opioid metabolism and response, such as specific gene variants, to better understand risks for respiratory depression, nausea, opioid dependence, and chronic pain after surgery. The study involves approximately 300 children aged 10 to 21 undergoing spine fusion surgery. Participants will have pharmacokinetic blood sampling to measure methadone and oxycodone levels and preoperative genotyping for genes influencing opioid metabolism. Genetic results will not be shared with care providers during treatment to maintain standard prescribing practices while researchers develop personalized dosing guidelines. Participants will be monitored immediately after surgery and up to one year at home for opioid-related side effects and pain relief effectiveness. Assessments include genetic testing, blood sample collection, clinical evaluations, and follow-up on opioid dosing and adverse outcomes. The main outcomes focus on genetic predisposition to opioid adverse effects and pain control, with safety and dosing impact analyzed during the perioperative period.
CONDITIONS
Brief Title
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children ages 10 to 21 years
- ASA physical status 1 to 3
- Undergoing posterior-lateral spinal fusion surgery
- Receiving inpatient opioid treatment
- Prescribed opioids at hospital discharge
You will not qualify if you...
- Presence of serious illness
- Severe pain before surgery
- Preoperative opioid use or misuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week before surgery
Participants undergo genetic testing to identify variants affecting opioid metabolism to personalize pain management.
1 visit (in-person) in the pre-operative clinic
Duration - Surgery day through post-operative day 4
Participants receive personalized perioperative analgesia during and immediately after spine fusion surgery, including opioid dosing guided by genetic factors.
Inpatient visits during surgery and daily monitoring for up to 4 days
Duration - Up to 1 year post-surgery
Participants are monitored at home for long-term opioid-related effects and pain relief for up to 1 year after surgery.
Trial Site Locations
Total: 5 locations
1
University of California
San Francisco, California, United States, 38456
Actively Recruiting
2
Children's Orthopaedic and Scoliosis Surgery Associates, LLP
St. Petersburg, Florida, United States, 33701
Not Yet Recruiting
3
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Not Yet Recruiting
4
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
S
Senthilkumar Sadhasivam, MD, MPH
D
Dayana Alsamsam, BSPS, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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