N/A
N=24
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Pain, Postoperative · Opioid Use · Recruitment
Bottom Line
View on ClinicalTrials.gov: NCT04500613 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Patients Who Receive Bilateral, Pre-incision ESPB — 9; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone (Procedure); No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) (Other)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Receive Bilateral, Pre-incision ESPB |
9; 12 | — |
| SECONDARY Rate of Recruitment |
12; 12 | — |
| SECONDARY Blinding Assessment |
0; -0.33 | — |
| SECONDARY Number of Participants Unable to Receive ESPB Block. |
2; 0 | — |
| SECONDARY Attrition |
3; 0 | — |
| SECONDARY Incidence of Intra- and Postoperative Complications Attributed to ESPB |
0; 0 | — |
| SECONDARY Pain Scores at Rest and Movement |
3.64; 3.58; 4; 2.5; 3.3; 3 | — |
| SECONDARY Total Opioid Consumption |
78.23; 53.89 | — |
| SECONDARY Time to First Opioid Use |
178; 94 | — |
| SECONDARY Opioid Related Side Effects |
3; 9; 6; 7; 1; 2 | — |
| SECONDARY Patient/Parent Satisfaction With Pain Management |
10; 8; 10; 9 | — |
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
Data sourced from ClinicalTrials.gov (NCT04500613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.