Personalized pain management for children undergoing spine surgery
Official title: Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Run by University of Pittsburgh · NCT05367609 · Data updated 2026-11-12
This study is testing a new way to manage pain for children having spine surgery by using their genetic information to customize how much pain medication they get.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 21 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 5 sites (San Francisco, California and 4 other locations) |
| Status | Recruiting |
| Started | September 20, 2022 |
| Main results expected | April 30, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT05367609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 10 to 21 who are undergoing posterior-lateral spinal fusion and require inpatient opioid treatment.
✕Probably not a fit
Patients with serious illnesses, severe preoperative pain, or a history of opioid misuse may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop a personalized perioperative analgesia platform (PPAP) that links genetic factors to opioid metabolism in order to improve pain management for children undergoing posterior spinal fusion surgery. The approach involves preoperative genotyping to identify genetic variants that may predispose children to adverse effects from opioids, such as respiratory depression and opioid dependence. By tailoring opioid dosing based on these genetic insights, the study seeks to enhance pain relief and minimize complications associated with opioid use in the postoperative period.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective pain management strategies for pediatric patients undergoing major surgeries.
How similar studies have gone: Other studies have shown promise in using genetic factors to personalize opioid therapy, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California
San Francisco, California, United States Recruiting -
Riley Children's Hospital
Indianapolis, Indiana, United States Recruiting -
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States Recruiting -
Children's Orthopaedic and Scoliosis Surgery Associates, LLP
St. Petersburg, Florida, United States Not yet recruiting -
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States Not yet recruiting
Study contacts
- Principal investigator: Senthilkumar Sadhasivam, MD, MPH — University of Pittsburgh
- Study coordinator: Senthilkumar Sadhasivam, MD, MPH
- Email: sadhasivams@upmc.edu
- Phone: 4126472994
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ear (auricular) vagus nerve stimulation to lower inflammation after long spinal fusion
This trial will test whether non-invasive ear-based vagus nerve stimulation can lower inflammation, improve blood sugar control, and reduce pain after long-segment spinal fusion surgery.
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We will see if giving intravenous magnesium during open thoracolumbar spine fusion changes motor-evoked potential monitoring in adults having the operation.
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This study is testing how ketamine affects nerve function in adults having spinal surgery to see if it can improve safety and pain management during the procedure.
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This study is testing if giving a sleep aid called zolpidem to patients having spine surgery can help them recover better and feel less pain.
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This study is testing whether a new bone graft extender called MagnetOs Flex Matrix works better than Trinity Elite for helping patients with degenerative disc disease heal after spinal fusion surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.