drugset / Trial / NCT02721017
Cryoanalgesia vs. Epidural in the Nuss Procedure
Phase 4
Completed
20 enrolled
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabFood and Drug Administration (FDA) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether cryoanalgesia provides better pain control for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.
Timeline
- Start
- 2016-05
- Primary completion
- 2018-08-28
- Completion
- 2018-09
Publications
- Background Graves C, Idowu O, Lee S, Padilla B, Kim S. Intraoperative cryoanalgesia for managing pain after the Nuss procedure. J Pediatr Surg. 2017 Jun;52(6):920-924. doi: 10.1016/j.jpedsurg.2017.03.006. Epub 2017 Mar 16.
- Results Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 2 mg/ml | Other |
| Comparator | Ropivacaine | Other / unclassified | 0.1 % | Other |