Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04153994
Status
Recruiting
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Conditions

  • Scoliosis; Adolescence
  • Scoliosis; Juvenile

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Erector Spinae Plane Blockade — PROCEDURE
    The ESPB is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Study Details

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.

Key Dates

Start date
Aug 28, 2020
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erector Spinae Plane Blockade Treatment
    Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.
  • No Intervention: Erector Spinae Plane Blockade Control - Standard of Care
    Patients will receive the standard of care for pediatric scoliosis surgery including multi-modal opioid pain management. If the patient declines to consent to enrollment into the randomized study, patients may still participate by allowing prospective data and samples collection/analysis with respect to perioperative choice.

Primary Outcome Measure

Length of Stay (LOS) [ Time Frame: Through hospital stay, an average of 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucille Packard Children's HospitalPalo AltoCalifornia94304
Ban Tsui, MD

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Lucille Packard Children's Hospital· Palo Alto, CA

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