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NCT05367609 · ClinicalTrials.gov registry record · NA
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
A NA study of Spine Fusion and PPAP, sponsored by Senthil Sadhasivam.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT05367609: Recruiting NA study of Spine Fusion and PPAP, sponsored by Senthil Sadhasivam.
NCT05367609 is a NA study of Spine Fusion and PPAP that is actively recruiting participants, run by Senthil Sadhasivam. The registered enrollment target is 300 participants, above the 87-participant average among 6 other Spine Fusion trials with a reported enrollment target (245% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05367609, a NA study of Spine Fusion and PPAP, is actively recruiting participants, sponsored by Senthil Sadhasivam.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Preoperative Genotyping
Study Locations (3)
California
- University of California - San Francisco
Indiana
- Riley Children's Hospital - Indianapolis
Pennsylvania
- UPMC Children's Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT05367609 shows while recruiting
NCT05367609 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 6 other Spine Fusion trials with a reported enrollment target (245% higher).
The record links to 2 conditions, with Spine Fusion appearing as the primary indexed condition, and to 1 intervention - of which Preoperative Genotyping is the first listed.
NCT05367609 reports a single indexed study location in California, Indiana, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05367609 about?
NCT05367609 is a clinical study titled "Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)". 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.
What is the current status of trial NCT05367609?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-09-20. Estimated completion is 2026-09.
What conditions does trial NCT05367609 study?
This clinical trial studies the following conditions: Spine Fusion, PPAP.
What interventions are being tested in trial NCT05367609?
The interventions under investigation include: Preoperative Genotyping (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05367609?
This trial is sponsored by Senthil Sadhasivam, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05367609 being conducted?
This trial has 3 study locations across California, Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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