Recruiting

Erector Spinae Plane Blockade

Sponsor:

Stanford University

Code:

NCT04153994

Conditions

Scoliosis; Juvenile

Scoliosis; Adolescence

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Erector Spinae Plane Blockade

Study Details

Brief summary:

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

Scoliosis; Juvenile

Scoliosis; Adolescence

Study ID

NCT04153994

Start date

Aug 28, 2020

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA I-III
  • Diagnosed with Idiopathic scoliosis
  • Undergoing single-stage posterior spinal instrumentation and fusion

Exclusion Criteria:

  • Thorascopic tethering procedure
  • Two-stage procedure
  • Abnormal developmental profile
  • Congenital/neuromuscular scoliosis
  • Requiring PICU admission
  • Known allergy to lidocaine
  • Known cardiac, renal or liver disease or dysfunction
  • Pre-existing pain complaints, i.e. on regular analgesic medications
  • Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
  • Requiring non-standard post-op pain management
  • Any history of seizures
  • Unplanned staged procedure
  • Weight < 5th centile or > 85th centile for age
  • Porphyria

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Erector Spinae Plane Blockade

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.

Primary outcome measure

  • Length of Stay (LOS) [ Time Frame: Through hospital stay, an average of 5 days ]
  • Postoperative Opioid Consumption [ Time Frame: Through hospital stay, an average of 5 days ]
  • Maximum lidocaine plasma concentration [Cmax] [ Time Frame: Through hospital stay, an average of 5 days ]
  • Patient-Reported Pain Scores [ Time Frame: Through hospital stay, an average of 5 days ]
  • Inpatient Postoperative Mobility [ Time Frame: Through hospital stay, an average of 5 days ]

Central Contacts and Locations

Central contacts

Ban Tsui, MD

(650)200-9107bantsui@stanford.edu

Chynna Villanueva, BS, RN

6504986346chynnav@stanford.edu

Locations

Lucille Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

More Information

Sponsor

Stanford University

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • Erector Spinae Plane Blockade
  • Pediatric Scoliosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-01.