Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID04153994

Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Using Surgically Placed Catheters

Led by Stanford University · Updated on 2025-05-01

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pain management after spinal fusion surgery for idiopathic scoliosis in children and adolescents. The trial evaluates the use of the erector spinae plane block (ESPB), a new regional anesthesia technique, to improve pain control and reduce opioid use after surgery. The study also investigates how this approach affects the body's inflammatory response related to acute pain after major surgery. Participants are randomly assigned to receive either the ESPB before surgery or the standard pain management care, which involves multiple types of pain relief including opioids. The ESPB involves injecting local anesthetic between muscles near the spine to block certain nerves, aiming to provide effective pain relief without affecting motor function. Patients who do not consent to randomization may still participate by allowing data and sample collection related to their perioperative care. During the hospital stay, which averages about five days, researchers will monitor length of stay, opioid use, lidocaine levels in the blood, patient-reported pain scores, and mobility after surgery. This study includes detailed assessments to understand the impact of ESPB on recovery and pain control in pediatric scoliosis surgery patients.

CONDITIONS

Brief Title

Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status I to III
  • Diagnosed with idiopathic scoliosis
  • Scheduled for single-stage posterior spinal instrumentation and fusion surgery
Not Eligible

You will not qualify if you...

  • Undergoing thoracoscopic tethering procedure
  • Planned two-stage procedure
  • Abnormal developmental profile
  • Diagnosed with congenital or neuromuscular scoliosis
  • Requiring pediatric intensive care unit admission
  • Known allergy to lidocaine
  • Known heart, kidney, or liver disease or dysfunction
  • Pre-existing pain requiring regular analgesic medications
  • Current psychiatric diagnosis such as anxiety, depression, or eating disorder
  • Need for non-standard postoperative pain management
  • History of seizures
  • Unplanned staged surgical procedure
  • Weight below 5th or above 85th percentile for age
  • Diagnosis of porphyria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Through hospital stay, an average of 5 days

Participants receive an erector spinae plane blockade prior to their pediatric scoliosis surgery or standard care with multi-modal opioid pain management during their hospital stay.

Hospital stay visits for approximately 5 days

Trial Site Locations

Total: 1 location

1

Lucille Packard Children's Hospital

Palo Alto, California, United States, 94304

Actively Recruiting

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Research Team

B

Ban Tsui, MD

C

Chynna Villanueva, BS, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report.

Carlos Rodrigues Almeida, Ana Raquel Oliveira, Pedro Cunha

https://pubmed.ncbi.nlm.nih.gov/30758122

Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series.

Josh P Melvin, Rudolph J Schrot, George M Chu...

https://pubmed.ncbi.nlm.nih.gov/29704223