Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT04153994

Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

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

50

Participants Needed

1

Research Sites

274 weeks

Total Duration

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AI-Summary

What this Trial Is About

Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.

CONDITIONS

Official 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
  • Undergoing single-stage posterior spinal instrumentation and fusion surgery
Not Eligible

You will not qualify if you...

  • Thoracoscopic tethering procedure
  • Two-stage procedure
  • Abnormal developmental profile
  • Congenital or neuromuscular scoliosis
  • Require PICU admission
  • Known allergy to lidocaine
  • Known cardiac, renal, or liver disease or dysfunction
  • Pre-existing pain complaints or regular analgesic use
  • Current psychiatric diagnosis such as anxiety, depression, or eating disorder
  • Require non-standard post-operative pain management
  • Any history of seizures
  • Unplanned staged procedure
  • Weight below 5th percentile or above 85th percentile for age
  • Porphyria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

C

Chynna Villanueva, BS, RN

CONTACT

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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