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

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 Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Recruitment; Opioid Use
• Intervention / Treatment: Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone; Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery (HSS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who receive bilateral, pre-incision ESPB	Rate of adherence, number who enroll, number who receive the intervention and complete all assessments	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Recruitment	Number screened/number enrolled	through study completion, an average of 1 year
Blinding Assessment	Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.	24 hours after surgery
Type and incidence of factors preventing performance of the block	Patient, surgical, anesthetic, and/or work flow related barriers	Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
Attrition	Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons	through study completion, an average of 1 year
Incidence of intra- and postoperative complications attributed to ESPB	Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness	During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
Pain Scores at Rest and Movement	Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine)	PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery)
Total Opioid Consumption	Measured in mean oral morphine equivalents (OME)	0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery)
Time to first opioid use	Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid	Up to 24 hours after surgery
Opioid Related Side Effects	Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS) (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)	24 hours after surgery
Patient/parent satisfaction with pain management	Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)	At hospital discharge (average 48 hours after surgery)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Jordan Ruby, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2021
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (ACTUAL): August 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Pain, Postoperative; Scoliosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: 2019-2131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No