Clinical trial NCT04500613: Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Official title: Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Opioid Use
Recruitment
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Receive Bilateral, Pre-incision ESPB
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Rate of Recruitment
timeFrame: through study completion, an average of 1 year
measure: Blinding Assessment
timeFrame: 24 hours after surgery
measure: Number of Participants Unable to Receive ESPB Block.
timeFrame: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
measure: Attrition
timeFrame: through study completion, an average of 1 year
measure: Incidence of Intra- and Postoperative Complications Attributed to ESPB
timeFrame: During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
measure: Pain Scores at Rest and Movement
timeFrame: PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)
measure: Total Opioid Consumption
timeFrame: 0-24 hours after surgery (OME within 24 hrs)
measure: Time to First Opioid Use
timeFrame: Up to 24 hours after surgery
measure: Opioid Related Side Effects
timeFrame: 24 hours after surgery
measure: Patient/Parent Satisfaction With Pain Management
timeFrame: At hospital discharge (an average of 4 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery (HSS)
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jordan Ruby, MD
role: PRINCIPAL_INVESTIGATOR
References: