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NCT06626503 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
A Phase 3 study of Idiopathic Scoliosis, sponsored by Senthil Sadhasivam.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT06626503: Recruiting Phase 3 study of Idiopathic Scoliosis, sponsored by Senthil Sadhasivam.
NCT06626503 is a Phase 3 study of Idiopathic Scoliosis that is actively recruiting participants, run by Senthil Sadhasivam. The registered enrollment target is 500 participants, above the 273-participant average among 3 other Idiopathic Scoliosis trials with a reported enrollment target (83% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06626503, a Phase 3 study of Idiopathic Scoliosis, is actively recruiting participants, sponsored by Senthil Sadhasivam.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing1,2 and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.
Primary Outcome
Average postoperative pain scores at 48-hours timepoint using 0-10, Numerical Rating Scale (NRS), in which 0=no pain at all and 10=worst pain imaginable. Outcome will be reported based on area under the curve (AUC) as mean(SD).
Conditions Studied
Interventions
- DRUG Methadone based ERAS
- DRUG Non-methadone based group
Study Locations (1)
Pennsylvania
- UPMC Children's Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-10-30 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 3 |
What NCT06626503 shows while recruiting
NCT06626503 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 273-participant average among 3 other Idiopathic Scoliosis trials with a reported enrollment target (83% higher).
The record links to 1 condition, with Idiopathic Scoliosis appearing as the primary indexed condition, and to 2 interventions - of which Methadone based ERAS is the first listed.
NCT06626503 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06626503 about?
NCT06626503 is a clinical study titled "Evaluation of Analgesia for Spine Fusion Elective Surgery in Children". The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) prot...
What is the current status of trial NCT06626503?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-10-30. Estimated completion is 2029-08-31.
What conditions does trial NCT06626503 study?
This clinical trial studies the following conditions: Idiopathic Scoliosis.
What interventions are being tested in trial NCT06626503?
The interventions under investigation include: Methadone based ERAS (DRUG), Non-methadone based group (DRUG).
Who is sponsoring clinical trial NCT06626503?
This trial is sponsored by Senthil Sadhasivam, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06626503 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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