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

Status: Completed
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• Age 10-19 years old

• Patients undergoing multilevel posterior spinal instrumentation and fusion

• Undergoing surgery for correction of adolescent idiopathic scoliosis

• Patients under the care of participating surgeons

• English Speaking

Locations
United States
New York
Hospital for Special Surgery (HSS)
New York
Time Frame
Start Date: 2021-02-22
Completion Date: 2022-12-02
Participants
Target number of participants: 24
Treatments
Active_comparator: ESPB with Bupivacaine and Dexamethasone
12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
Placebo_comparator: No ESPB
12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov