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Local Anesthetic

Methadone vs EXPAREL for Pediatric Scoliosis Pain Management (AIMS Trial)

Phase 4

Recruiting

Led By Casey Stondell, MD

Research Sponsored by Dr. Casey Stondell, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

AIMS Trial Summary

This trial aims to compare the effectiveness of 2 drugs to manage pain in kids with scoliosis. If successful, a larger study will measure effectiveness of the drugs.

Who is the study for?

This trial is for kids aged 11-17 with juvenile or adolescent idiopathic scoliosis who are having spinal fusion surgery. They must be generally healthy (ASA Class 1-2) and not have chronic pain, opioid use, severe allergies to study drugs, liver/kidney issues, seizure disorders, obesity (BMI ≥35), or conditions preventing surgery like pregnancy.Check my eligibility

What is being tested?

The study compares two pain management methods after scoliosis surgery in children: an erector spinae plane blockade using Exparel versus intravenous methadone. It's a small-scale test run to see if a larger trial would work.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, potential breathing difficulties from methadone, and local complications such as infection at the injection site for Exparel.

AIMS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful Enrollment and Data Collection of 30 Subjects

Secondary outcome measures

Length of Stay

Opioid Consumption

Pain Scores

AIMS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal Bupivacaine (LB, Exparel)Experimental Treatment1 Intervention

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.

Group II: Intravenous (IV) MethadoneActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Pacira Pharmaceuticals, IncIndustry Sponsor

136 Previous Clinical Trials

14,003 Total Patients Enrolled

Pacira Biosciences Inc.UNKNOWN

Dr. Casey Stondell, MDLead Sponsor

Media Library

Liposomal bupivacaine (LB, Exparel) (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05730920 — Phase 4

Adolescent Idiopathic Scoliosis Research Study Groups: Intravenous (IV) Methadone, Liposomal Bupivacaine (LB, Exparel)

Adolescent Idiopathic Scoliosis Clinical Trial 2023: Liposomal bupivacaine (LB, Exparel) Highlights & Side Effects. Trial Name: NCT05730920 — Phase 4

Liposomal bupivacaine (LB, Exparel) (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05730920 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to partake in this clinical trial?

"This medical research requires 30 adolescents between the ages of 11 and 17 diagnosed with idiopathic scoliosis; they must also adhere to a range of criteria, such as American Society of Anesthesiologists (ASA) class 1-2 and parental agreement. The trial is intended for those that will be undergoing posterior spinal fusion surgery."

Answered by AI

Do any individuals below the age of fifty-five qualify for this experiment?

"Participants between the ages of 11 and 17 are eligible to enroll in this research project."

Answered by AI

Could you explain the potential risks associated with using Liposomal Bupivacaine (LB, Exparel)?

"Our specialists at Power have given Liposomal Bupicacaine (LB, Exparel) a score of 3 due to the completion of Phase 4 trials. These results demonstrate that this treatment has been approved for use by governing bodies."

Answered by AI

Are individuals currently able to join this experiment?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical study, which was first posted on October 19th 2022, is currently recruiting patients from one location and looking for 30 participants to enrol in the trial."

Answered by AI

How extensive is the reach of this research endeavor?

"Indeed, clinicaltrials.gov has verified that this medical study is currently recruiting patients. It was initially posted on October 19th 2022 and modified most recently on February 15th 2023; 30 participants are needed from 1 particular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dr. Casey Stondell, MD 2022. "IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730920.

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