NCT05367609 Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
| NCT ID | NCT05367609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Senthil Sadhasivam |
| Condition | PPAP |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-20 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-09-20 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Senthilkumar Sadhasivam, MD, MPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05367609 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying PPAP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05367609 currently recruiting?
Yes, NCT05367609 is actively recruiting participants. Contact the research team at sadhasivams@upmc.edu for enrollment information.
Where is the NCT05367609 trial being conducted?
This trial is being conducted at San Francisco, United States, St. Petersburg, United States, St. Petersburg, United States, Indianapolis, United States and 1 additional location.
Who is sponsoring the NCT05367609 clinical trial?
NCT05367609 is sponsored by Senthil Sadhasivam. The principal investigator is Senthilkumar Sadhasivam, MD, MPH at University of Pittsburgh. The trial plans to enroll 300 participants.