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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
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.
Patients who are randomized to this group will not receive a bilateral erector spinae plane block
Hospital for Special Surgery (HSS)
New York, New York, United States
Number of Patients Who Receive Bilateral, Pre-incision ESPB
number who receive the intervention and complete all assessments
Time frame: through study completion, an average of 1 year
Rate of Recruitment
Number enrolled and allocated to specific group
Time frame: 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 or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.
Time frame: 24 hours after surgery
Number of Participants Unable to Receive ESPB Block.
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.
Time frame: 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.
Time frame: 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
Time frame: 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). NRS was collected for each participant, Mean and Standard Deviations are found below.
Time frame: PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)
Total Opioid Consumption
Measured in mean oral morphine equivalents (OME)
Time frame: 0-24 hours after surgery (OME within 24 hrs)
Time to First Opioid Use
Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Time frame: Up to 24 hours after surgery
Opioid Related Side Effects
Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.
Time frame: 24 hours after surgery
Patient/Parent Satisfaction With Pain Management
Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Time frame: At hospital discharge (an average of 4 days)
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