Trials / Completed
CompletedNCT04500613
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Hospital for Special Surgery, New York · Academic / Other
- Sex
- All
- Age
- 10 Years – 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone | Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. |
| OTHER | No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) | Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
Timeline
- Start date
- 2021-02-22
- Primary completion
- 2022-11-28
- Completion
- 2022-12-02
- First posted
- 2020-08-05
- Last updated
- 2024-12-27
- Results posted
- 2024-12-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04500613. Inclusion in this directory is not an endorsement.