IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction (AIMS)

A Single-center, Randomized, Single-blind Pilot Study to Evaluate Intravenous Methadone Versus EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Adolescent and Juvenile 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.

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis
• Intervention / Treatment: Drug: Methadone; Drug: Liposomal bupivacaine (LB, Exparel)

Detailed Description

Enrolled subjects will be randomized to one of two groups: one group will receive intra-operative IV methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (ESPB) with liposomal bupivacaine (LB, Exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. All other aspects of peri-operative management will be standardized. Subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. Upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. Subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous (IV) Methadone; Subjects will receive IV methadone 0.2 mg/kg (maximum dose 20mg) via an infusion pump over 15 minutes while undergoing continuous monitoring. Additional IV methadone may be given during the case per the anesthesiologist's discretion, but the total dose may not exceed 20mg.	Drug: Methadone; IV Methadone
Experimental: Liposomal Bupivacaine (LB, Exparel); Subjects will receive four-point ESPB with an admixture of LB and 0.25% bupivacaine hydrochloride. The total LB dose will be 4mg/kg, max dose of 266mg, while the total dose of bupivacaine hydrochloride will be 2mg/kg.	Drug: Liposomal bupivacaine (LB, Exparel); LB and bupivacaine hydrochloride via erector spinae plane blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Enrollment and Data Collection of 30 Subjects	Assess the feasibility of completing a prospective randomized trial pilot study comparing Erector Spinae Plane Blockade (ESPB) with liposomal bupivacaine (LB) to intravenous methadone at a single institution in two years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Assess whether there is a difference in post-operative opioid consumption between the two study groups. This will evaluated by converting all long-acting opioids to daily morphine equivalents per unit of weight.	2 years
Pain Scores	Assess whether there is a difference in post-operative pain scores between the two study groups. Visual analog scale (VAS) scores with a minimum of 0 and a maximum of 10 will be used where 0 is no pain and 10 is the worst pain imaginable	2 years
Length of Stay	Assess whether there is a difference in hospital length of stay between the two study groups	2 years

Collaborators and Investigators

• Sponsor: Dr. Casey Stondell, MD
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Casey Stondell, MD, Shriners Children's

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): July 16, 2024
• Study Completion (Actual): September 21, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; scoliosis; exparel; methadone; regional anesthesia; erector spinae plane block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Respiratory System Agents; Antitussive Agents; Bupivacaine; Methadone
• Other Study ID Numbers: NCA2205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes