IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
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 (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (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.
Conditions:
Adolescent Idiopathic Scoliosis Juvenile Idiopathic Scoliosis
Study Start (Actual) 2022-10-19
Primary Completion (Estimated) 2024-06-01
Study Completion (Estimated) 2025-06-01
Enrollment (Estimated) 30
Study Type INTERVENTIONAL
Phase PHASE4
Locations:
📍 Sacramento, California, United States

Eligibility Criteria

Description

    Inclusion Criteria:

    • * Subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (ICF) for the subject to participate in the study
    • * Patients with a diagnosis of juvenile idiopathic scoliosis (JIS) or adolescent idiopathic scoliosis (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 liposomal bupivacaine (LB, Exparel)
    • * 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.
Ages Eligible for Study: 11 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2023-01-25
  • First Submitted that Met QC Criteria2023-02-06
  • First Posted2023-02-16

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-04-15
  • Last Update Posted2024-04-17
  • Last Verified2024-04