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NCT04500613 · ClinicalTrials.gov registry record · NA
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
A NA study of Pain, Postoperative and Opioid Use, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04500613: Completed NA study of Pain, Postoperative and Opioid Use, sponsored by Hospital for Special Surgery, New York.
NCT04500613 is a NA study of Pain, Postoperative and Opioid Use that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 24 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04500613, a NA study of Pain, Postoperative and Opioid Use, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population. The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.
Primary Outcome
number who receive the intervention and complete all assessments
Conditions Studied
Interventions
- PROCEDURE Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
- OTHER No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
Study Locations (1)
New York
- Hospital for Special Surgery (HSS) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2022-12-02 |
| Phase | NA |
What the finished NCT04500613 record still lists
NCT04500613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone is the first listed.
NCT04500613 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04500613 about?
NCT04500613 is a clinical study titled "Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis". Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique t...
What is the current status of trial NCT04500613?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-02-22. Estimated completion is 2022-12-02.
What conditions does trial NCT04500613 study?
This clinical trial studies the following conditions: Pain, Postoperative, Opioid Use, Recruitment.
What interventions are being tested in trial NCT04500613?
The interventions under investigation include: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone (PROCEDURE), No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) (OTHER).
Who is sponsoring clinical trial NCT04500613?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04500613 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04500613's enrollment target sits among peer trials
24 108th of 113 higher than 5 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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