drugset / Trial / NCT05730920
IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-10-19
- Primary completion
- 2024-07-16
- Completion
- 2024-09-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 2 mg/kg | Other |
| Subject | Bupivacaine | Other / unclassified | 4 mg/kg | Other |
| Comparator | Methadone | Other / unclassified | 0.2 mg/kg | Intravenous |