CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04500613
NCT04500613N/ACompleted

Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study

Hospital for Special Surgery, New York·interventional·Posted Aug 5, 2020·Updated Dec 27, 2024

In Brief

A clinical study evaluating Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone and No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) for Pain, Postoperative and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 5, 2020
Enrollment StartFeb 22, 2021
Primary CompletionNov 28, 2022
Study CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.9 years ago

Interventions

Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasoneprocedure

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.

No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)other

Patients who are randomized to this group will not receive a bilateral erector spinae plane block