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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 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 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04500613
The ClinicalTrials.gov registry entry for NCT04500613 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (91% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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