IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic… (NCT05730920) | Clinical Trial Compass
CompletedPhase 4
IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
United States30 participantsStarted 2022-10-19
Plain-language 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.
Who can participate
Age range
11 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful Enrollment and Data Collection of 30 Subjects