Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Not Applicable

Completed

Conditions: Pain, Postoperative
Recruitment
Opioid Use

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

Registration Number: NCT04500613

Lead Sponsor: Hospital for Special Surgery, New York

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No ESPB	No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)	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.
ESPB with Bupivacaine and Dexamethasone	Bilateral Erector Spinae Plane Block 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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Receive Bilateral, Pre-incision ESPB	through study completion, an average of 1 year	number who receive the intervention and complete all assessments

Secondary Outcome Measures

Name	Time	Method
Rate of Recruitment	through study completion, an average of 1 year	Number enrolled and allocated to specific group
Attrition	through study completion, an average of 1 year	Number of patients who enroll but do not receive the intervention and/or study assessments.
Blinding Assessment	24 hours after surgery	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 or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.
Number of Participants Unable to Receive ESPB Block.	Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery	Number of participants who were randomized to receive the ESPB block, but were unable to receive the block. The no ESPB group were randomized not to get the ESPB block, leading to 0 instances of missed ESPB block.
Incidence of Intra- and Postoperative Complications Attributed to ESPB	During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery	Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
Pain Scores at Rest and Movement	PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)	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). NRS was collected for each participant, Mean and Standard Deviations are found below.
Total Opioid Consumption	0-24 hours after surgery (OME within 24 hrs)	Measured in mean oral morphine equivalents (OME)
Time to First Opioid Use	Up to 24 hours after surgery	Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Patient/Parent Satisfaction With Pain Management	At hospital discharge (an average of 4 days)	Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Opioid Related Side Effects	24 hours after surgery	Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.