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

Primary Purpose

Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methadone
Liposomal bupivacaine (LB, Exparel)
Sponsored by
Dr. Casey Stondell, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring scoliosis, methadone, exparel, regional anesthesia, erector spinae plane block, pediatric

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shriners Hospitals for ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous (IV) Methadone

Liposomal Bupivacaine (LB, Exparel)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Length of Stay
Assess whether there is a difference in hospital length of stay between the two study groups

Full Information

First Posted
January 25, 2023
Last Updated
February 15, 2023
Sponsor
Dr. Casey Stondell, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05730920
Brief Title
IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
Acronym
AIMS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Casey Stondell, MD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 (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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
Keywords
scoliosis, methadone, exparel, regional anesthesia, erector spinae plane block, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous (IV) Methadone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Liposomal Bupivacaine (LB, Exparel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
IV Methadone
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine (LB, Exparel)
Intervention Description
LB and bupivacaine hydrochloride via erector spinae plane blocks
Primary Outcome Measure Information:
Title
Successful Enrollment and Data Collection of 30 Subjects
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
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.
Time Frame
2 years
Title
Pain Scores
Description
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
Time Frame
2 years
Title
Length of Stay
Description
Assess whether there is a difference in hospital length of stay between the two study groups
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey Stondell, MD
Phone
916-453-2066
Email
cstondell@shrinenet.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sundeep Tumber, DO
Phone
916-453-2066
Email
stumber@shrinenet.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Stondell, MD
Organizational Affiliation
Shriners Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Molnar
Phone
916-453-2136
Email
emolnar@gmail.com
First Name & Middle Initial & Last Name & Degree
Casey Stondell, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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