Clinical Trial Finder

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.

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.

Arms

Interventions