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

NCT05730920 | Completed Phase 4 FDA Drug

• 1 other identifier: NCA2205
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Keywords

scoliosis; methadone; exparel; regional anesthesia; erector spinae plane block; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Opioid Consumption

  2 years

• Pain Scores

  2 years

• Length of Stay

  2 years

Study Arms (2)

Intravenous (IV) Methadone

ACTIVE COMPARATOR

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

Liposomal Bupivacaine (LB, Exparel)

EXPERIMENTAL

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)

Interventions

Methadone DRUG

IV Methadone

Intravenous (IV) Methadone

Liposomal bupivacaine (LB, Exparel) DRUG

LB and bupivacaine hydrochloride via erector spinae plane blocks

Liposomal Bupivacaine (LB, Exparel)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Casey Stondell, MD: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Shriners Hospitals for Children

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Methadone

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Casey Stondell, MD

  Shriners Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 16, 2023
• Study Start: October 19, 2022
• Primary Completion: July 16, 2024
• Study Completion: September 21, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)