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

NCT ID: NCT05730920

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2024-09-21

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.

Conditions

Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Methadone

Intervention Type: DRUG

IV Methadone

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine (LB, Exparel)

Intervention Type: DRUG

LB and bupivacaine hydrochloride via erector spinae plane blocks

Interventions

Methadone

IV Methadone

Intervention Type: DRUG

Liposomal bupivacaine (LB, Exparel)

LB and bupivacaine hydrochloride via erector spinae plane blocks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Dr. Casey Stondell, MD

OTHER

Sponsor Role: lead

Responsible Party

Dr. Casey Stondell, MD

Pediatric Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Casey Stondell, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Children's

Locations

Shriners Hospitals for Children

Sacramento, California, United States

Countries

United States

Other Identifiers

NCA2205

Identifier Type: -

Identifier Source: org_study_id