IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade with EXPAREL to IV methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Casey Stondell, MD
• Treatments: Bupivacaine; Methadone

Criteria

Inclusion Criteria:

• Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study

• Patients with a diagnosis of JIS or AIS who will have posterior spinal fusion surgery

• Male or female patients 11 to less than 18 years of age on the day of surgery.

• American Society of Anesthesiologists (ASA) Class 1-2.

• Able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

• Body mass index ≥35 at the time of screening

• Contraindication to regional anesthesia (e.g., abnormal coagulation, infection at site)

• Current opioid use at the time of screening

• Current diagnosis of chronic pain

• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications

• Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration

• Subject/parent/guardian primary language other than English or Spanish

• Inability of patient to verbally express symptoms such as pain and side effects (as in moderate to severe developmental delay)

• A prolonged QTc on preoperative EKG (QTc longer than 450 milliseconds)

• History of Torsades de Pointes

• Renal or hepatic impairment

• Diagnosed active seizure disorder

• Any other condition that causes patient to be ineligible for surgery, i.e. pregnancy.