Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Stanford University

Status: Enrolling

Conditions: Scoliosis; Adolescence; Scoliosis; Juvenile

Treatments: Procedure: Erector Spinae Plane Blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT04153994

52852

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Erector Spinae Plane Blockade Treatment

Experimental group

Description:

Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.

Treatment:

Procedure: Erector Spinae Plane Blockade

Erector Spinae Plane Blockade Control - Standard of Care

No Intervention group

Description:

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.