Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Recruitment; Pain, Postoperative; Opioid Use

Treatments: Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone); Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04500613

2019-2131

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients younger than 10 years old or older than 19 years old
• Neuromuscular scoliosis
• Patient under the care of non-participating surgeon performing the procedure
• History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks)
• Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin)
• Allergy, intolerance, or contraindication to any protocol component/study medication/technique
• Patient or parent refusal
• Non-english speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

ESPB with Bupivacaine and Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone

No ESPB

Placebo Comparator group

Description:

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.

Treatment:

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